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  • UK

    £50000 - £60000 per annum, Benefits
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    Senior Manager, Regulatory Affairs, NBG

    An innovative and patient focused pharma company is recruiting for a Senior Manager, Regulatory Affairs (NBG)

    This fantastic opportunity will allow you to lead the development of the Neuroscience Business Group regulatory strategy team. Providing an exceptional package consisting of salary, performance-based incentives, top-tier benefits, a comprehensive wellness program, and innovative work-life solutions.

    As Senior Manager you will be the EU Regulatory Lead for an early phase compound. The Senior Manager will have important input in supporting European regulatory activities for Orphan diseases. You will be involved in supporting European regulatory activities for an innovative rare diseases pipeline. The Senior Manager will have the opportunity to contribute to innovative global regulatory strategies as well as be involved in US regulatory activities.

    Leading the design of clinical development programmes will be an important part of the role. Upcoming submission work will include leading the preparation of an orphan drug application, a PIP and clinical trial applications for Phase 2/3. Close working with US based Global cross-functional Project Teams in the UK, US and Japan will be part of the role. Involvement in post-approval work for Centralised products may also be involved.

    As a Senior Manager, NBG prior experience with EU scientific advice, PIPs and orphan drugs as well as some experience in neurosciences therapy area is desirable. You will need prior experience in the resolution of regulatory risks as well as experience in submissions of CTA/MAA. Life cycle management and interfacing with regulatory authorities. All the above will be part of this diverse and exciting role. The Senior Manager will be influential with the financial budget, matrix and team. Strategic experience and forward thinking, cognitive capabilities as well as great organisational and problem-solving skills are required. A BSc/MSc relevant to the role is desired.

    This Senior Manager NBG Regulatory role is an office-based position in greater London with flexibility. A fantastic permanent opportunity with a competitive salary and package.

    Skills Alliance is a preferred supplier for this brilliant opportunity. Please contact Iman Osman for more details on +44 207 220 6220.

    Reference #IOSMNBG

  • UK

    £63000 - £73000 per annum, Benefits
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    Associate Director, Regulatory Affairs, NBG

    An innovative and patient focused pharma company is recruiting for an Associate Director, Regulatory Affairs (NBG)

    This fantastic opportunity will allow you to support the key development of the Neuroscience Business Group regulatory strategy team. Providing an exceptional package consisting of salary, performance-based incentives, top-tier benefits, a comprehensive wellness program, and innovative work-life solutions.

    As Associate Director you will be leading the European Regulatory activities for an orphan disease pipeline. You will contribute to innovative global regulatory strategies and have opportunity for the involvement in US regulatory activities.

    The Associate Director, will also be the EU Regulatory Lead for an early phase compound, where input to global regulatory strategy including design of clinical development programmes will be an important part of the role. Upcoming submission work will include leading the preparation of an orphan drug application, a PIP and clinical trial applications for Phase 2/3. Close working with US based Global Regulatory Leads and cross-functional Project Teams in the UK, US and Japan will be required. Involvement in post-approval work for Centralised products may also be involved.

    As Associate Director, NBG prior experience with EU scientific advice, PIPs and orphan drugs as well as some experience in neurosciences therapy areas is desirable. Experience with EU and/or UK regulatory processes and environment, including clinical trials, Regulatory strategy experience and strong strategic thinking skills are needed. As Associate Director, NBG you will be liaising and negotiating with regulatory authorities, both verbally and in writing. You will need prior experience in submissions of CTA/MAA and life cycle management. As Associate Director you must be able to operate in a complex environment and adapt well.

    This is a diverse and exciting role that requires an experienced and forward-thinking individual who will be at the helm of their resource, financial and matrix team management. Strong organisational and problem-solving skills and a BSc/MSc relevant to the role is desired.

    The Associate Director, NBG Regulatory role is an office-based position with flexibility. A fantastic permanent opportunity with a competitive salary and package.

    Skills Alliance is a preferred supplier for this brilliant opportunity. Please contact Iman Osman for more details on +44 207 220 6220.

    Reference #IOADNBG

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    Manager, Regulatory Affairs, NBG

    An innovative and patient focused pharma company is recruiting for a Manager, Regulatory Affairs (NBG)

    This fantastic opportunity will allow you to support the development of the Neuroscience Business Group regulatory strategy team. Providing an exceptional package consisting of salary, performance-based incentives, top-tier benefits, a comprehensive wellness program, and innovative work-life solutions.

    As Manager you will be involved in supporting the European Regulatory activities for an orphan disease pipeline. You will contribute to innovative global regulatory strategies and have opportunities for involvement in US regulatory activities.

    The appointed person will also be the EU Regulatory Lead for an early phase compound, where input to global regulatory strategy including design of clinical development programmes will be an important part of the role. Upcoming submission work will include leading the preparation of an orphan drug application, a PIP and clinical trial applications for Phase 2/3. Close working with US based Global Regulatory Leads and cross-functional Project Teams in the UK, US and Japan will be required for both above. Involvement in post-approval work for Centralised products may also be involved.

    As a Manager, NBG prior experience with EU scientific advice, PIPs and orphan drugs as well as some experience in neuroscience therapy areas is desirable. Experience with EU and/or UK regulatory processes and environment, including clinical trials, Regulatory strategy experience and strong strategic thinking skills are needed. As Manager, NBG you will be liaising and negotiating with regulatory authorities, both verbally and in writing. You must be able to operate in a complex environment and adapt well. You will need prior experience in submissions of CTA/MAA. Life cycle management.

    This is a diverse and exciting role that requires an experienced and forward-thinking individual. Strong organisational and problem-solving skills and a BSc/MSc relevant to the role is desired.

    The Manager, NBG Regulatory role is an office-based position with flexibility. A fantastic permanent opportunity with a competitive salary and package.

    Skills Alliance is a preferred supplier for this brilliant opportunity. Please contact Iman Osman for more details on +44 207 220 6220.

  • $60000 - $70000 per annum
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    An emerging Medical Technology Company is urgently seeking PhD graduates, specialized in Chemistry for an opportunity to get experience on the business side. The role will be remote, home-based on the East Coast.

    Reporting into the Senior Account Manager, the responsibilities will be to build and maintain relationships, pursue objectives and meet timelines to achieve company goals, provide technical support and training on software, and provide results on new product developments of software.

    Ideal candidate must have a Chemistry related PhD and should be comfortable pitching to clients.Experience with account management or sales is desired.Experience with software applications/medical technology or scientific data is a plus.

  • £90000 - £110000 per annum, Benefits
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    Director, Regulatory Affairs

    A global biopharmaceutical company developing life-changing medicines is recruiting for a Director of Regulatory Affairs in Oxford, United Kingdom.

    This is an opportunity to be a key stakeholder in the companies’ Regulatory activities. This global biopharmaceutical is passionate about developing meaningful medicines, bringing them to people with unaddressed needs around the world. As Director you will play a key role in seeking solutions for rare or complex diseases, and ensuring solutions are available for the often-overlooked patients in need.

    As Director your role will be to initiative and oversee regulatory activities of product development and life cycle management for licensed products. You will support the company’s efforts to obtain and maintain agreements with Health Authorities globally to market products. The Director of Regulatory Affairs will manage worldwide interactions and negotiations with regulatory agencies, internal stakeholders, and partners in support of product registrations and continuity of supply. As a key member you may also be leading project teams while also overseeing junior regulatory team members.

    Essential Functions

    • Manage partnerships from regulatory standpoint for products/projects
    • Review and approve labelling for the company’s products
    • Review documentation in support of commercial product (I.e. clinical protocols/CSRs and investigator brochures, quality, nonclinical, safety)
    • Ensure the timely preparation, review, and submission of investigational and product submissions such as INDs/CTAs/IMPDs, MAAs/BLAs/NDAs and variations for products/projects

    Required Knowledge, Skills, and Abilities

    • Deep and broad knowledge of regulatory affairs and requirements; direct experience with biological and/or pharmaceutical regulatory submissions and product approvals
    • Knowledge and experience in preparation of investigational and new product submissions with EU, US, and ex-US countries including eCTD format
    • Experience in preparation of global regulatory strategies
    • Experience with maintenance of regulatory authorizations and variations in at least two regions
    • Experience with supporting a project with development activities in at least two regions
    • Evaluative, analytical and interpretative skills enabling review and synthesis of reports and other documents used in regulatory planning and submissions

    Bachelors or Masters or advanced degree in a scientific discipline, with a proven track record of increasingly responsible regulatory experience in the pharmaceutical and/or biotech industry is desirable.

    As Director you will be provided with an incredibly competitive salary and flexible home/office based working hours.

    Skills Alliance is a preferred supplier for this brilliant opportunity. Please contact Iman Osman for more details on +44 207 220 6220.

    Reference #IODJ

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    A Global Research and Development organization has a pivotal hire to be made. This organization is looking for an Associate Director of Regulatory Affairs to join their team. The Associate Director would be acting as the strategist on a close-knit regulatory team. The Associate Director would report directly into the VP of the regulatory team and act as an individual contributor. As the Associate Director, you would responsible for all strategy focused tasks within this global organization including engagements with the FDA and other governing agencies. The Associate Director would be responsible for leading the IND strategies for this organization as well. The ideal candidate would have an advance degree like a PhD or Masters along with working knowledge of strategic matters for IND submissions. Ideally, the candidate would have engaged with the FDA on a couple accounts as well.

    The organization the Associate Director would be joining is partnered with one of the largest pharmaceutical companies in the world. This company functions as the R&D arm of this global company and has a robust pipeline of assets that cover multiple therapeutic areas. This gives the Associate Director the opportunity to lead multiple IND submissions in different therapeutic areas each year with the organization.

    For further consideration, please submit a copy or your resume.

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    PV Operations Leader

    An exciting research-based biopharmaceutical company is recruiting for an Associate Director/Director to play a key role in their Pharmacovigilance and Epidemiology department as a Pharmacovigilance Operations Clinical Leader.

    This is an opportunity to be part of a dynamic pharma with a global presence that is committed to discovering, developing and commercialising innovative medicines in areas of unmet medical need.

    The PV Operations Leader will be responsible for defining PVE project team strategies and managing functional and cross-functional projects. You will be a key representative of the PVE Operations management team. Overseeing PV Operational team activities associated with clinical trials management as well as clinical trial conventions, and/or clinical trial submission activities.

    You will be responsible for ensuring study management team leads are in compliance with all clinical trial reporting requirements to partners and regulators whilst establishing and/or identifying best practices of case quality, compliance, and process improvements.

    This exciting and challenging role requires you to utilize strong operational management skills ensuring successful outcomes of strategic business goals of the PVE. As Pharmacovigilance Operations Leader you will partner with Clinical Operation Study leads ensuring alignment of process handoffs between the clinical and PVE teams, including oversight of PVE work performed by Clinical CROs.

    In collaboration with senior members, you will identify and pursue global and long-term goals for the PV Operations team, taking into account and providing support for overall strategic goals for the department.
    Strong knowledge of clinical trial interactions, safety reporting and regulations from an international perspective is necessary. All of which will allow you to provide advice and support to other functional groups with respect to drug safety standards and the requirements pertaining to clinical trial standards.

    In-depth knowledge and thorough understanding of FDA, EU and global regulations, ICH guidelines, and GCPs that govern drug safety and pharmacovigilance is a must. Also desirable for the position is a degree in biological sciences, nursing, pharmacy or medicine.

    You will provide support and back-up to the Director or Group Head. Previous management experience is imperative as building a successful team will be an integral part of this opportunity

    This is a diversified and challenging position offering a competitive salary and benefits. It is an office-based role located in Hillingdon with the view to taking over EU and US teams long-term.

    Skills Alliance is a preferred supplier for this brilliant opportunity. Please contact Iman Osman for more details on +44 207 220 6220.

    Reference #IOPOCL

  • USA

    $110000 - $135000 per annum
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    An innovated top pharmaceutical company who focuses on first-in-class/best-in-class products and services has created a new Full-Time position and is looking to hire an in-house Manager, Regulatory Affairs (RA) for operations and submissions management within their New Jersey office. This is a great opportunity to join a top performing company while also gaining experience with pharmacovigilance and work alongside the Regulatory Strategist Team.

    As the Manager, you’ll be responsible for routine planning, publishing and electronic assembly of submissions. This company’s focus is on the creation of drug discovery projects and are backed by one of the biggest pharmaceutical organizations in the world. Due to such high volume of IND submissions we are seeking to complete on-boarding ASAP!

    Requirements:
    • Minimum of 2yrs experience with Regulatory Submissions in the pharmaceutical industry.
    • Knowledge and experience using publishing software and tools as well as the FDA’s (ESG).
    • Experience with IND submissions and eCTD
    • Ability to assist in coordination of global projects with team members.
    • Knowledge of FDA’s changing guidelines surrounding electronic submissions and data standards.

    Please email alex.f.a4lgdx1grbsp@skillsalliance.aptrack.co for future information.

  • USA

    $165000 - $180000 per annum
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    This is an excellent opportunity to join one of the most influential global pharmaceutical companies in the Greater Richmond area that are making an impact on the treatment and services of individuals who are fighting addiction. This can be a REMOTE based opportunity.

    As the Director of Government Affairs, you will serve in a highly visible position building a strong presence within state governments, public payers, and regulatory agencies across the domestic United States. Reporting directly into the VP of Government Affairs, the applicant will have a rare opportunity to influence and help ensure patient access to treatment.

    You will be responsible for representing the company on state legislative and regulatory affairs to government officials in regulatory and other government agencies. Building and managing relationships with state government officials and third-party groups will be a crucial aspect of this role. You will ensure that state policy and legislation allow for patient access to treatment while promoting credible partners and thought leaders.

    You must have a minimum of a bachelor’s degree in business, public health, or a related discipline. You must have at least 8 years of experience at the state level building relationships with regulatory and advocacy agencies. Having management experience within the pharmaceutical or an advocacy organization would be looked at favorably.

    The company is one of the most unique in the industry with a proven track record of success both domestic and abroad in the pain management/addition space. This is the right time to be joining this truly innovative team!

  • £30000 - £40000 per annum, Benefits
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    An exciting medical device start-up is recruiting for a Regulatory Analyst to join an award-winning and ambitious start-up.

    The medical device start-up is developing “magnetic blood filtration”, a revolutionary treatment for blood-borne diseases which removes pathogens directly from the bloodstream. The technology is like dialysis, circulating a patient’s blood through an external loop to remove disease causing targets. While dialysis relies on non-specific size-based filtration. This process uses magnetic particles coated with antibodies to target specific components, and magnetic forces to extract them.

    Your role
    As Regulatory Analyst, you will assist in drafting the company’s regulatory documentation, managing Technical Files and Quality Management Systems. You will work directly with the technical team and highly experienced Quality and Regulatory Director to help bring each product through the medical device regulatory pathway. This is an exciting opportunity to join an award-winning, ambitious start-up in which you can have a real impact during an exciting stage of development. In addition to a competitive salary, the company operates a stock option plan for its employees. The post is a full-time, permanent appointment, subject to a performance-based probation period of 6 months. The place of work will be in the company’s offices in London.

    Experience and Attributes
    You should have a Bachelors or Masters degree in Regulatory Affairs or a related area and at least 2 years relevant experience in industry. Excellent written communication skills, a high level of organisation and keen eye for detail ie required. In addition, you should have the following skills and attributes:

    • Good knowledge of EU Medical Device Regulations, including difference between MDD and MDR.
    • Understanding of EU regulatory pathway for Class II and Class III medical devices, including required tests and data to secure a CE mark.
    • Good knowledge of relevant ISO standards (e.g. 10993, 14971…).
    • Experience setting up and/or working under ISO 13485 approved QMS system.
    • Experience writing regulatory documentation, including risk assessments, technical files and design history files.
    • Ability to work independently to manage and prioritise workload and work collaboratively as part of a team.
    • Self-motivated, pro-active, innovative, enthusiastic and personable.

    This is a great position offering a competitive salary and benefits. It is an office-based role located in London.

    Skills Alliance is a preferred supplier for this brilliant opportunity. Please contact Iman Osman for more details on +44 207 220 6220.

    Reference #IORAM

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    A thriving company in Boston is looking for a Senior Manager – Clinical Supply. A product launch is expected very soon. Be part of a growing biotech! This is becoming one of the most desirable companies to work for. This is on site position with an ongoing contact.

    A Senior Manager, Clinical Supply has key responsibilities which include overseeing several global clinical trials, enlarging access programs, and Investigator Sponsored Trails (IST). In this role, you will work with the Clinical Supply Associate, Clinical Operations, and Quality Assurance. By doing this, you will grow clinical supply chains to be certain that clinical supplies are able to be obtained in a constant manner, and make sure they are ready to be viewed for an inspection. You can also be creative and think of ways the company and over excel.

    An undergraduate degree in Life Sciences is required. You must have anywhere between 5-12 years experience in clinical supply management, or experience in a pharmaceutical/biopharmaceutical setting. Desirable candidates will have experience in CMO management. This is not limited to assigning, wrapping, and administering in North America and Europe. One should also have experience with IRT system and execution. Have a basic understanding of cGMPS and FDA and EU Regulations. Get accustomed with global regulatory agencies and counseling.

    • CRO management experience
    • Clinical Supply
    • Regulatory knowledge
    • Global regulations knowledge
    • Monitor inventory levels
    • Manage packaging timelines

    If you are interested in learning more about this opportunity, please email me at alex.f.a4lgdx1gre2r@skillsalliance.aptrack.co

  • £90000 - £110000 per annum, Benefits
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    Director, Regulatory Affairs

    A global biopharmaceutical company developing life-changing medicines is recruiting for a Director of Regulatory Affairs in Oxford, United Kingdom.

    This is an opportunity to be a key stakeholder in the companies’ Regulatory activities. This global biopharmaceutical is passionate about developing meaningful medicines, bringing them to people with unaddressed needs around the world. As Director you will play a key role in seeking solutions for rare or complex diseases, and ensuring solutions are available for the often-overlooked patients in need.

    As Director your role will be to initiative and oversee regulatory activities of product development and life cycle management for licensed products. You will support the company’s efforts to obtain and maintain agreements with Health Authorities globally to market products. The Director of Regulatory Affairs will manage worldwide interactions and negotiations with regulatory agencies, internal stakeholders, and partners in support of product registrations and continuity of supply. As a key member you may also be leading project teams while also overseeing junior regulatory team members.

    Essential Functions

    • Manage partnerships from regulatory standpoint for products/projects
    • Review and approve labelling for the company’s products
    • Review documentation in support of commercial product (I.e. clinical protocols/CSRs and investigator brochures, quality, nonclinical, safety)
    • Ensure the timely preparation, review, and submission of investigational and product submissions such as INDs/CTAs/IMPDs, MAAs/BLAs/NDAs and variations for products/projects

    Required Knowledge, Skills, and Abilities

    • Deep and broad knowledge of regulatory affairs and requirements; direct experience with biological and/or pharmaceutical regulatory submissions and product approvals
    • Knowledge and experience in preparation of investigational and new product submissions with EU, US, and ex-US countries including eCTD format
    • Experience in preparation of global regulatory strategies
    • Experience with maintenance of regulatory authorizations and variations in at least two regions
    • Experience with supporting a project with development activities in at least two regions
    • Evaluative, analytical and interpretative skills enabling review and synthesis of reports and other documents used in regulatory planning and submissions

    Bachelors or Masters or advanced degree in a scientific discipline, with a proven track record of increasingly responsible regulatory experience in the pharmaceutical and/or biotech industry is desirable.

    As Director you will be provided with an incredibly competitive salary and flexible home/office based working hours.

    Skills Alliance is a preferred supplier for this brilliant opportunity. Please contact Iman Osman for more details on +44 207 220 6220.

    Reference #IODJ

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    Before applying for this position you need to submit your online CV. Click the button below to continue.


    Share

    Manager, Regulatory Affairs, NBG

    An innovative and patient focused pharma company is recruiting for a Manager, Regulatory Affairs (NBG)

    This fantastic opportunity will allow you to support the development of the Neuroscience Business Group regulatory strategy team. Providing an exceptional package consisting of salary, performance-based incentives, top-tier benefits, a comprehensive wellness program, and innovative work-life solutions.

    As Manager you will be involved in supporting the European Regulatory activities for an orphan disease pipeline. You will contribute to innovative global regulatory strategies and have opportunities for involvement in US regulatory activities.

    The appointed person will also be the EU Regulatory Lead for an early phase compound, where input to global regulatory strategy including design of clinical development programmes will be an important part of the role. Upcoming submission work will include leading the preparation of an orphan drug application, a PIP and clinical trial applications for Phase 2/3. Close working with US based Global Regulatory Leads and cross-functional Project Teams in the UK, US and Japan will be required for both above. Involvement in post-approval work for Centralised products may also be involved.

    As a Manager, NBG prior experience with EU scientific advice, PIPs and orphan drugs as well as some experience in neuroscience therapy areas is desirable. Experience with EU and/or UK regulatory processes and environment, including clinical trials, Regulatory strategy experience and strong strategic thinking skills are needed. As Manager, NBG you will be liaising and negotiating with regulatory authorities, both verbally and in writing. You must be able to operate in a complex environment and adapt well. You will need prior experience in submissions of CTA/MAA. Life cycle management.

    This is a diverse and exciting role that requires an experienced and forward-thinking individual. Strong organisational and problem-solving skills and a BSc/MSc relevant to the role is desired.

    The Manager, NBG Regulatory role is an office-based position with flexibility. A fantastic permanent opportunity with a competitive salary and package.

    Skills Alliance is a preferred supplier for this brilliant opportunity. Please contact Iman Osman for more details on +44 207 220 6220.

  • UK

    £50000 - £60000 per annum, Benefits
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    Senior Manager, Regulatory Affairs, NBG

    An innovative and patient focused pharma company is recruiting for a Senior Manager, Regulatory Affairs (NBG)

    This fantastic opportunity will allow you to lead the development of the Neuroscience Business Group regulatory strategy team. Providing an exceptional package consisting of salary, performance-based incentives, top-tier benefits, a comprehensive wellness program, and innovative work-life solutions.

    As Senior Manager you will be the EU Regulatory Lead for an early phase compound. The Senior Manager will have important input in supporting European regulatory activities for Orphan diseases. You will be involved in supporting European regulatory activities for an innovative rare diseases pipeline. The Senior Manager will have the opportunity to contribute to innovative global regulatory strategies as well as be involved in US regulatory activities.

    Leading the design of clinical development programmes will be an important part of the role. Upcoming submission work will include leading the preparation of an orphan drug application, a PIP and clinical trial applications for Phase 2/3. Close working with US based Global cross-functional Project Teams in the UK, US and Japan will be part of the role. Involvement in post-approval work for Centralised products may also be involved.

    As a Senior Manager, NBG prior experience with EU scientific advice, PIPs and orphan drugs as well as some experience in neurosciences therapy area is desirable. You will need prior experience in the resolution of regulatory risks as well as experience in submissions of CTA/MAA. Life cycle management and interfacing with regulatory authorities. All the above will be part of this diverse and exciting role. The Senior Manager will be influential with the financial budget, matrix and team. Strategic experience and forward thinking, cognitive capabilities as well as great organisational and problem-solving skills are required. A BSc/MSc relevant to the role is desired.

    This Senior Manager NBG Regulatory role is an office-based position in greater London with flexibility. A fantastic permanent opportunity with a competitive salary and package.

    Skills Alliance is a preferred supplier for this brilliant opportunity. Please contact Iman Osman for more details on +44 207 220 6220.

    Reference #IOSMNBG

  • £80000 - £95000 per annum, Benefits
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    Associate Director, Global CMC

    A fantastic opportunity to join an innovative bio pharmacetical company that is recruiting for an Associate Director of Regulatory Affairs, Global CMC.

    The Associate Director position, Global CMC will be responsible for managing, leading registration and providing CMC regulatory support for commercial and development projects worldwide with a bio pharma that has had products approved every year since 2016. Providing an exceptional package consisting of salary, stock options and top-tier benefits.

    As Associate Director, CMC you will be responnsible for the planning and co-ordination of writing and reviewing Module 2 and 3 CTD sections for all regulatory submissions (INDs, IMPDs, CTAs, MAAs, NDAs, BLAs, meeting requests, and briefing documents). You will lead functional/department multi-disciplinary teams in complex, business critical projects to establish Regulatory CMC strategies for commercial products, late and early stage development programs. Solve unique and complex problems that have a broad impact on the function and/or broader department.

    As Associate Director you will provide in-depth reviews of protocols, reports, presentations, and documents, anticipating internal and/or external business challenges and/or regulatory issues
    You will be required to regularly interact with functional leaders and in some cases senior leadership and/or major customers, on matters concerning functional area, business unit or additional business areas., including regulatory agency interactions.

    As Associte Director you will be experienced in identifying and leading for continuous improvement opportunities for the GRA-CMC team and the broader GRA team. In addition to this you must monitor EU and US CMC regulations assessing any changes to ensure all development activities are in compliance with applicable current regulations and guidelines. Experience with electronic Common Technical Document CMC regulatory documents (MAA, BLA, variations, responses and CTAs/INDs). In depth knowledge of FDA, EMA and ICH guidelines is also required.

    This Director of Regulatory Affairs role is an office-based position based is in the Oxfordshire area. Offering a competitive salary and package.

    Skills Alliance is a preferred supplier for this opportunity. Please contact Iman Osman for more details on +44 207 220 6220.
    #IOADCMCJ

  • UK

    £90000 - £110000 per annum, Benefits
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    Director Regulatory Affairs (New products)

    A fantastic opportunity to join an innovative bio pharmacetical company that is recruiting for a Director (New Products) appointment.

    This positions you as a leading member within a bio pharma which, has had products approved every year since 2016. Providing an exceptional package consisting of salary, stock options and top-tier benefits.
    As Director you will be a key stakeholder in the company’s regulatory activities focusing efforts to obtain worldwide approvals to market products.

    The Director, Regulatory Affairs will manage worldwide interactions and negotiations with regulatory agencies and marketing partners in support of investigational studies, product registrations, and commercial products. Strong leadership skills and strategic implementation is a key focus for this role.

    As Director you will have had experience resolving complex issues in creative and effective ways. Supervising activities that include planning and co-ordination of the writing and reviewing of all regulatory submissions (INDs, IMPDs, CTAs, MAAs, NDAs, BLAs, meeting requests, and briefing documents).

    You will ensure the internal review and submission of these items have been appropriately managed, providing an in-depth reviews of Review of protocols, Investigator Brochures, IND/IMPDs, reports quality, safety, efficacy and labelling) including CTAs, anticipating internal and/or external business challenges and/or regulatory issues will be required.

    As Director you will work with Global Regulatory Lead to support regulatory budget and resource needs for molecule assessing the resource requirement to support molecule strategic objectives.
    You will be xperienced in maintenaning regulatory authorizations in at least one region and experience with supporting a project with development activities in at least two regions is desirable.

    This Director of Regulatory Affairs role is an office-based position based is in the Oxfordshire area. Offering a competitive salary and package.

    Skills Alliance is a preferred supplier for this opportunity. Please contact Iman Osman for more details on +44 207 220 6220.
    #IODNPJ

  • UK

    £90000 - £110000 per annum, Benefits
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    Director Regulatory Affairs

    A fantastic opportunity to join an innovative bio pharmacetical company that is recruiting for a Director (post marketing) appointment.

    This opportunity will position you as a leading member within a bio pharma which, has had products approved every year since 2016. Providing an exceptional package consisting of salary, stock options and top-tier benefits.

    As Director you will be a key stakeholder in the company’s regulatory activities and oversee the activities of product development and life cycle management for established products. You will be liasing with authorites globally to market products. As Director of Regulatory Affairs you will manage worldwide interactions and negotiations with stakeholders, agencies and partners to ensure continuity of supply. Strong leadership and strategic implementation is a key focus for this role.

    You will be responsible for managing partnerships from a regulatory standpoint for products/projects and the review and approval of labelling for the company’s products. You must have strong experience with documentation in support of commercial products (I.e. clinical protocols/CSRs and investigator brochures, quality, nonclinical, safety) and ensure the timely preparation, review, and submission of investigational and product submissions such as INDs/CTAs/IMPDs, MAAs/BLAs/NDAs and variations for products/projects.

    As Director you will oversee direct reports in preparation and management of above responsibilities and assist as needed. This exciting role requires you to have a deep and broad knowledge of regulatory affairs and direct experience with biological and/or pharmaceutical regulatory submissions and product approvals. You must have a proven track record of effective collaboration with regulatory agencies knowledge and experience in preparation of investigational and new product submissions with EU, US, and ex-US countries including eCTD format as well as experience in preparation of global regulatory strategies

    A proven record of maintenance of regulatory authorizations and variations in at least two regions and supporting a project with development activities in at least two regions is desirable.

    This Director of Regulatory Affairs role is an office-based position based is in the Oxfordshire area. Offering a competitive salary and package.

    Skills Alliance is a preferred supplier for this opportunity. Please contact Iman Osman for more details on +44 207 220 6220.
    #IODPMJ

  • UK

    £90000 - £110000 per annum, Benefits
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    Director Regulatory Affairs

    A fantastic opportunity to join an innovative bio pharmacetical company that is recruiting for a Director (post marketing) appointment.

    This opportunity will position you as a leading member within a bio pharma which, has had products approved every year since 2016. Providing an exceptional package consisting of salary, stock options and top-tier benefits.

    As Director you will be a key stakeholder in the company’s regulatory activities and oversee the activities of product development and life cycle management for established products. You will be liasing with authorites globally to market products. As Director of Regulatory Affairs you will manage worldwide interactions and negotiations with stakeholders, agencies and partners to ensure continuity of supply. Strong leadership and strategic implementation is a key focus for this role.

    You will be responsible for managing partnerships from a regulatory standpoint for products/projects and the review and approval of labelling for the company’s products. You must have strong experience with documentation in support of commercial products (I.e. clinical protocols/CSRs and investigator brochures, quality, nonclinical, safety) and ensure the timely preparation, review, and submission of investigational and product submissions such as INDs/CTAs/IMPDs, MAAs/BLAs/NDAs and variations for products/projects.

    As Director you will oversee direct reports in preparation and management of above responsibilities and assist as needed. This exciting role requires you to have a deep and broad knowledge of regulatory affairs and direct experience with biological and/or pharmaceutical regulatory submissions and product approvals. You must have a proven track record of effective collaboration with regulatory agencies knowledge and experience in preparation of investigational and new product submissions with EU, US, and ex-US countries including eCTD format as well as experience in preparation of global regulatory strategies

    A proven record of maintenance of regulatory authorizations and variations in at least two regions and supporting a project with development activities in at least two regions is desirable.

    This Director of Regulatory Affairs role is an office-based position based is in the Oxfordshire area. Offering a competitive salary and package.

    Skills Alliance is a preferred supplier for this opportunity. Please contact Iman Osman for more details on +44 207 220 6220.
    #IODPMJ

  • UK

    £90000 - £110000 per annum, Benefits
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    Director Regulatory Affairs (New products)

    A fantastic opportunity to join an innovative bio pharmacetical company that is recruiting for a Director (New Products) appointment.

    This positions you as a leading member within a bio pharma which, has had products approved every year since 2016. Providing an exceptional package consisting of salary, stock options and top-tier benefits.
    As Director you will be a key stakeholder in the company’s regulatory activities focusing efforts to obtain worldwide approvals to market products.

    The Director, Regulatory Affairs will manage worldwide interactions and negotiations with regulatory agencies and marketing partners in support of investigational studies, product registrations, and commercial products. Strong leadership skills and strategic implementation is a key focus for this role.

    As Director you will have had experience resolving complex issues in creative and effective ways. Supervising activities that include planning and co-ordination of the writing and reviewing of all regulatory submissions (INDs, IMPDs, CTAs, MAAs, NDAs, BLAs, meeting requests, and briefing documents).

    You will ensure the internal review and submission of these items have been appropriately managed, providing an in-depth reviews of Review of protocols, Investigator Brochures, IND/IMPDs, reports quality, safety, efficacy and labelling) including CTAs, anticipating internal and/or external business challenges and/or regulatory issues will be required.

    As Director you will work with Global Regulatory Lead to support regulatory budget and resource needs for molecule assessing the resource requirement to support molecule strategic objectives.
    You will be xperienced in maintenaning regulatory authorizations in at least one region and experience with supporting a project with development activities in at least two regions is desirable.

    This Director of Regulatory Affairs role is an office-based position based is in the Oxfordshire area. Offering a competitive salary and package.

    Skills Alliance is a preferred supplier for this opportunity. Please contact Iman Osman for more details on +44 207 220 6220.
    #IODNPJ

  • £80000 - £95000 per annum, Benefits
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    Associate Director, Global CMC

    A fantastic opportunity to join an innovative bio pharmacetical company that is recruiting for an Associate Director of Regulatory Affairs, Global CMC.

    The Associate Director position, Global CMC will be responsible for managing, leading registration and providing CMC regulatory support for commercial and development projects worldwide with a bio pharma that has had products approved every year since 2016. Providing an exceptional package consisting of salary, stock options and top-tier benefits.

    As Associate Director, CMC you will be responnsible for the planning and co-ordination of writing and reviewing Module 2 and 3 CTD sections for all regulatory submissions (INDs, IMPDs, CTAs, MAAs, NDAs, BLAs, meeting requests, and briefing documents). You will lead functional/department multi-disciplinary teams in complex, business critical projects to establish Regulatory CMC strategies for commercial products, late and early stage development programs. Solve unique and complex problems that have a broad impact on the function and/or broader department.

    As Associate Director you will provide in-depth reviews of protocols, reports, presentations, and documents, anticipating internal and/or external business challenges and/or regulatory issues
    You will be required to regularly interact with functional leaders and in some cases senior leadership and/or major customers, on matters concerning functional area, business unit or additional business areas., including regulatory agency interactions.

    As Associte Director you will be experienced in identifying and leading for continuous improvement opportunities for the GRA-CMC team and the broader GRA team. In addition to this you must monitor EU and US CMC regulations assessing any changes to ensure all development activities are in compliance with applicable current regulations and guidelines. Experience with electronic Common Technical Document CMC regulatory documents (MAA, BLA, variations, responses and CTAs/INDs). In depth knowledge of FDA, EMA and ICH guidelines is also required.

    This Director of Regulatory Affairs role is an office-based position based is in the Oxfordshire area. Offering a competitive salary and package.

    Skills Alliance is a preferred supplier for this opportunity. Please contact Iman Osman for more details on +44 207 220 6220.
    #IOADCMCJ

  • UK

    £50000 - £60000 per annum, Benefits
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    Senior Manager, Regulatory Affairs, NBG

    An innovative and patient focused pharma company is recruiting for a Senior Manager, Regulatory Affairs (NBG)

    This fantastic opportunity will allow you to lead the development of the Neuroscience Business Group regulatory strategy team. Providing an exceptional package consisting of salary, performance-based incentives, top-tier benefits, a comprehensive wellness program, and innovative work-life solutions.

    As Senior Manager you will be the EU Regulatory Lead for an early phase compound. The Senior Manager will have important input in supporting European regulatory activities for Orphan diseases. You will be involved in supporting European regulatory activities for an innovative rare diseases pipeline. The Senior Manager will have the opportunity to contribute to innovative global regulatory strategies as well as be involved in US regulatory activities.

    Leading the design of clinical development programmes will be an important part of the role. Upcoming submission work will include leading the preparation of an orphan drug application, a PIP and clinical trial applications for Phase 2/3. Close working with US based Global cross-functional Project Teams in the UK, US and Japan will be part of the role. Involvement in post-approval work for Centralised products may also be involved.

    As a Senior Manager, NBG prior experience with EU scientific advice, PIPs and orphan drugs as well as some experience in neurosciences therapy area is desirable. You will need prior experience in the resolution of regulatory risks as well as experience in submissions of CTA/MAA. Life cycle management and interfacing with regulatory authorities. All the above will be part of this diverse and exciting role. The Senior Manager will be influential with the financial budget, matrix and team. Strategic experience and forward thinking, cognitive capabilities as well as great organisational and problem-solving skills are required. A BSc/MSc relevant to the role is desired.

    This Senior Manager NBG Regulatory role is an office-based position in greater London with flexibility. A fantastic permanent opportunity with a competitive salary and package.

    Skills Alliance is a preferred supplier for this brilliant opportunity. Please contact Iman Osman for more details on +44 207 220 6220.

    Reference #IOSMNBG

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    Manager, Regulatory Affairs, NBG

    An innovative and patient focused pharma company is recruiting for a Manager, Regulatory Affairs (NBG)

    This fantastic opportunity will allow you to support the development of the Neuroscience Business Group regulatory strategy team. Providing an exceptional package consisting of salary, performance-based incentives, top-tier benefits, a comprehensive wellness program, and innovative work-life solutions.

    As Manager you will be involved in supporting the European Regulatory activities for an orphan disease pipeline. You will contribute to innovative global regulatory strategies and have opportunities for involvement in US regulatory activities.

    The appointed person will also be the EU Regulatory Lead for an early phase compound, where input to global regulatory strategy including design of clinical development programmes will be an important part of the role. Upcoming submission work will include leading the preparation of an orphan drug application, a PIP and clinical trial applications for Phase 2/3. Close working with US based Global Regulatory Leads and cross-functional Project Teams in the UK, US and Japan will be required for both above. Involvement in post-approval work for Centralised products may also be involved.

    As a Manager, NBG prior experience with EU scientific advice, PIPs and orphan drugs as well as some experience in neuroscience therapy areas is desirable. Experience with EU and/or UK regulatory processes and environment, including clinical trials, Regulatory strategy experience and strong strategic thinking skills are needed. As Manager, NBG you will be liaising and negotiating with regulatory authorities, both verbally and in writing. You must be able to operate in a complex environment and adapt well. You will need prior experience in submissions of CTA/MAA. Life cycle management.

    This is a diverse and exciting role that requires an experienced and forward-thinking individual. Strong organisational and problem-solving skills and a BSc/MSc relevant to the role is desired.

    The Manager, NBG Regulatory role is an office-based position with flexibility. A fantastic permanent opportunity with a competitive salary and package.

    Skills Alliance is a preferred supplier for this brilliant opportunity. Please contact Iman Osman for more details on +44 207 220 6220.

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    A leading Pharmaceuticals company in Oxfordshire are seeking a Talent Acquisition Coordinator for an initial 12-month contract. There is potential for this to extend or turn into a permanent position for the right candidate.

    The chosen applicant will be responsible for:

    • Managing contract-worker compliance and all contract extension processes across the business
    • Managing contractors becoming permanent employees – managing process with the recruitment agencies and internal stakeholders
    • Interview coordination and general administration
    • Hands-on recruitment and candidate attraction for scientific vacancies

    Required experience:

    • Experience working within a Pharmaceuticals or Biotechnology company
    • 2+ years’ experience in recruitment coordination or administration
    • Motivated individual who is passionate about progressing their recruitment career within Life Sciences

    Please apply today for immediate consideration or contact Sarah Brambill from Skills Alliance for more information.

  • £60000 - £70000 per annum
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    A world-class mid-size pharma are recruiting for an EMEA Medical Advisor position based in the Hertfordshire area.

    You will have the opportunity to join a patient-driven global pharmaceutical company located north of London, who have an extensive Neurology portfolio and are expanding worldwide, offering you opportunities for progression and growth.

    This is a cross-functional and strategic Medical Affairs role at EMEA level. You would liaise with the EMEA Scientific Director to support EMEA Medical Affairs plans, provide scientific, medical and technical support, marketing, training and sales activities for the Neurology portfolio in line with the EMEA strategy.

    The EMEA Medical Advisor position is an office-based role offering flexibility to work from home and international travel involved. The salary offered is between £ 60000-70000 (depending on experience) + benefits + bonus + car allowance.

    Previous Medical Affairs experience and GMC/GPhC registration is required.

    Medical Final Signatory is preferred.

    Skills Alliance are the preferred company for this role. For more information about this opportunity or any similar opportunities, please contact Silvia Gullone on 0044 (0)207 220 6219.

  • £75000 - £85000 per annum, Bonus and Benefits
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    A leading Biotech organization based in Central London are recruiting for a Principal Investigator to supervise early phase trials.

    You will have the opportunity to join an expanding company which is a pioneering clinical trial platform for the development of Respiratory Disease products. Their portfolio also includes Infectious Disease and Immunology.

    The role will be an exciting opportunity for physicians working in clinical development to gain exposure in phase I/II trials and work in close contact with the patients. In cooperation with other clinical units, the Principal Investigator will lead the staff during the development of clinical trials, along with supervising patient screenings and directing medical duties.

    The Principal Investigator position is an office-based role located in the heart of London. It is a permanent position offering around 75-85K depending on the experience + bonus and benefits. GMC registration is required.

    Skills Alliance are the preferred company for this role. For more information about this opportunity or any similar opportunities, please contact Silvia Gullone on 0044 (0)207 220 6219.

  • £95000 - £115000 per annum
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    A world-class mid-size pharma are recruiting for an EMEA Medical Director position based in the Hertfordshire area.

    You will have the opportunity to join a patient-driven global pharmaceutical company located north of London, who have an extensive Oncology portfolio and are expanding worldwide, offering you opportunities for progression and growth.

    This is a cross-functional and strategic Medical Affairs role at EMEA level with global responsibilities. You would liaise with the Head of Medical Affairs at EMEA level to develop and implement EMEA Medical Affairs plans, provide scientific, medical and technical support, marketing, training and sales activities for the Oncology portfolio and collaborate with regional and global business development teams.

    The EMEA Medical Director position is an office-based role offering flexibility to work from home and international travel involved. The salary offered is between £95,000-115,000 (depending on experience) + benefits + bonus + car allowance.

    Medical Final Signatory is required.

    Skills Alliance are the preferred company for this role. For more information about this opportunity or any similar opportunities, please contact Silvia Gullone on 0044 (0)207 220 6219.

  • £60000 - £70000 per annum
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    ***ENTRY/JUNIOR LEVEL MEDICAL ADVISOR ROLE***

    A world-class mid-size pharma are recruiting for an EMEA Medical Advisor position based in the Hertfordshire area.

    You will have the opportunity to join a patient-driven global pharmaceutical company located north of London, who have an extensive Neurology portfolio and are expanding worldwide, offering you opportunities for progression and growth.

    This is a cross-functional and strategic Medical Affairs role at EMEA level. You would liaise with the EMEA Team to support EMEA Medical Affairs plans, provide scientific, medical and technical support, marketing, training and sales activities for the Neurology portfolio in line with the EMEA strategy.

    The EMEA Medical Advisor position is an office-based role offering flexibility to work from home and international travel involved. The salary offered is between £ 60000-70000 (depending on experience) + benefits + bonus + car allowance.

    GMC/GPhC registration is required, as well as NEUROLOGY experience.

    Skills Alliance are the preferred company for this role. For more information about this opportunity or any similar opportunities, please contact Silvia Gullone on 0044 (0)207 220 6219.

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    Job Summary

    • Provide Quality Support to Device Development, to ensure products are designed and tested in accordance to applicable industry standards, regulatory requirements, and Vectura and customer requirements.
    • Provide guidance and implement strategies for driving product quality and continuous improvement.
    • Management of the Device Development Department (recruitment, presence, tasks, training). Establishment of continuous surveillance of progress within the group.

    Principal Accountabilities

    • Responsibility for assuring that the product is designed and tested in compliance with applicable standards and regulations.
    • Supports on device development activities such as Design History File, Product Specifications, Product Technical Requirement (PTR) development and testing, packaging development and risk management.
    • Development of risk management planning and activities.
    • As a manager in the quality team, oversee and coordinate the activities of quality engineers and technicians.
    • Maintain existing Quality systems.
    • Provide support to ongoing certification to ISO13485.

    Experience

    • Possess understanding of regulatory requirements such as FDA Quality System Regulations, ISO 13485 and the EU Medical Device Directives.
    • Experience with the development of risk management planning and analysis.
    • Experience with Design Verification Test activities including test planning, test procedure and test report development.
    • High level of attention to detail with strong communication skills, both written and verbal.
    • Experience in product development and quality, preferably in a medical device environment.
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    Job Summary

    • Provide superior Quality Support to Supply Chain and Device Industrialization, to ensure products are manufactured in accordance to applicable industry standards, regulatory requirements, and Vectura and customer requirements.

    Principal Accountabilities

    • Support the analysis of reports and production data to identify trends and recommend updates or changes to quality standards and procedures when necessary.
    • Implement protocols and methods (including SOP’s) to ensure that incoming material and manufactured products are compliant with internal requirements as well as to standards/regulations.
    • Drive Key Process Indicators to determine process effectiveness, identify areas for improvement, best practices, scrap reduction and Supplier Quality improvement and drive continuous quality improvement projects with cross-functional teams.
    • Drive and manage corrective and preventive actions for issues related to quality.
    • Work closely with production line and ensure all necessary controls are enforced to be compliant with ISO 13485 and FDA QSR requirements.
    • Perform audits (Product-Specific and Quality System) and follow up on closure of any non-conformances; support supplier approval process and maintenance of the Approved Suppliers List and implement Quality Technical Agreements.
    • Maintain existing Quality systems by completing tasks as assigned by Quality Team Leader/Manager.
    • Provision of advice and guidance to project teams on good quality practices
    • Conducts Lessons Learnt as required to champion a culture of feedback and improvement

    Experience

    • Experience of working in a product development environment utilising CMOs for manufacture and supply
    • Good knowledge and experience of quality engineering tools such as APQP, SPC and SCAR.
    • Hands-on experience of electro-mechanical medical devices including Class I and Class IIa devices and PCB testing
    • Experience in evaluation and trending of dimensional data.
    • Experience with technical drawings and specifications.
    • Proven ability to use the quality, complaints, design control, corrective and preventive action, risk management, and non-conforming product systems and to extract and drive improvement initiatives.
    • Demonstrable experience in supplier quality management: quality concepts/tools/methods (e. g. FMEA, IQ/OQ/PQ, MSA, etc.), quality issue resolution and quality monitoring measures.
    • Highly experienced in leading internal and external audits
    • Strong communication and engagement skills with proven ability to drive continuous quality improvements
    • Excellent organisational skills
    • An ability to work flexibly, calmly and efficiently whilst responding to multiple priorities
    • Ability to communicate with and influence a range of stakeholders at all levels
  • $120000 - $140000 per annum
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    An innovative biopharmaceutical company is looking for a Program Manager (PM) in the greater Boston area to help with the planning and executing of programs. Their innovative plans for the discovery and development of novel therapeutics are to treat diseases caused by an imbalance of proteins and work with CF, genetic diseases and neurodegenerative diseases.

    Key Responsibilities:
    • Monitor the progress of programs and adjust as necessary with the Project Lead to ensure the successful completion of the program goals and objectives.
    • Work closely with the functional leads (i.e., SVP Clinical Development Operations) to update relevant stakeholders weekly on progress in all programs.
    • Lead project planning, develop and maintain timelines and coordinate deliverables in collaboration with program leads.
    • Collaborate with teams to support strategies through implementation for corporate goals
    • Responsible for confirming all department heads and all stakeholders are aligned with regards to each of the programs

    Qualifications:
    • B.S. / M.S., degree- preferably in Project Management
    • A minimum of 5 years (PM) experience in a biotech or related industry
    • Proficient with computer applications, Microsoft suite and MS Project
    • Able to learn and master other computer tech and software programs
    • Ability to work well with all levels of internal management and staff, as well as outside clients and vendors
    • Ability to work independently and in a team environment
    • Problem solving and strong communication skills a necessity

    Please contact Jen at alex.f.a4lgdx1grhxl@skillsalliance.aptrack.co for more information.

  • USA

    $140000 - $155000 per annum
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    This is an excellent opportunity to join one of the most exciting global Biotech’s in the Greater Boston area with a recent product launch in the rare disease therapeutic area.

    As the Director of Medical Communication, you will lead the publication planning and strategy for this ground-breaking product launch. The successful applicant will have the chance to have a leadership role and have an influential position in the organization.

    Reporting to the Senior Director Global Medical Communications, the applicant will have the opportunity to manage the Global Medical Communication team. You will be responsible for creating executing global medical communication strategy and creating high quality and impact global resources that communicate relevant disease-state data for this company’s therapeutics. You will work cross-functional and cross-geographic with partners including the Global Medical Affairs Leads and Clinical Development to inform and execute medical strategies. The successful candidate will be responsible for the development of medical communication resources aligned to global strategy for the company’s therapeutic.

    You must have a minimum of an advanced degree in biomedical sciences (PhD, MD or PharmD), and a minimum of two years of relevant experience in Medical Affairs and/or Medical Communication in a pharmaceutical or biotech setting. A background in the rare disease therapeutic area would be looked at favorably.

    The company is one of the most unique in the industry with a proven track record of success in the rare disease space. This is the right time to be joining this truly innovative team!

    If you are interested in more information on this role and further detail on the job description, please reach out to me at 646-300-8343 or alex.f.a4lgdx1grhxn@skillsalliance.aptrack.co

  • Competitive salary and benefits
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    An exciting CRO is looking for a Senior Research Nurse to join their expanding team in London.

    This is a great opportunity to join a company as they are looking to grow within the coming years.

    As they expand there will be excellent opportunities for progression and development as well as being involved in the decision-making process.

    You would be responsible for all trial related activities as well as training of staff. They require a Clinical Research Nurse with good knowledge of ICH-GCP regulatory framework.

    The Senior Research Nurse role is a full-time, permanent role with shifts. It offers a competitive salary and package.

    Skills Alliance are the preferred supplier for this role. Please contact Maria Matei for more details on +44(0)203 948 5299.

  • €110000 - €125000 per annum, Bonus, Handy, Laptop, Auto, Aktienpaket
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    Unser Klient ist derzeit eines der führenden Medizintechnik-Unternehmen auf dem Markt. Ein Innovatives Produkt, dass die Lebensqualität der Patienten verbessert.

    Aus diesem Grund suchen wir für die Region Zürich und Ostschweiz einen Clinical Consultant (m/w/d).


    Auf was Sie sich freuen können:

    – Patientenbetreuung durch eine fachgerechte Ausbildung und Beratung des medizinischen Personals
    – Reportings von klinisch relevanten Daten und Dokumentationen von Ergebnisse
    – Enge zusammenarbeit mit unseren Teammitgliedern und Vetriebskollegen
    – Klinische Beratung, Durchführung von Trainings und Verwaltung von Schulungen für unsere neueen und bestehenden Kunden
    – Trainings und Klinische Demos: Unterstützung bei der Koordination von klinischen Demos vor Ort.

    Was Sie mitnehmen sollten:

    – Erfolgreich abgeschlossene klinische oder technische Ausbildung idealerweise Erfahrung im Herzkatheterlabor
    – Mehrjährige Berufserfahrung in der direkten Patientenbetreuung auf Intensiv-oder Pflegestation
    – Mindestens zwei Berufsjahre Erfahrung im Aussendienst (=Industrieunternehmen)
    – Ausgezeichnete Kommunikations- und Präsentationsfähigkeiten sowie Teamfähigkeit
    – Hervorragende Deutsch– und Englischkenntnisse in Wort und Schrift
    – 50% Reisebereitschaft innerhalb der vorgegebenen Region und Einsetzbereitschaft für Notfallsituationen

    Bei Interesse und offene Fragen steht Ihnen unsere Kollegin Jessica Demirtas zur Verfügung unter der Nummer: +41 43 508 73 11.

    Bitte beachten Sie Gehaltsangaben in CHF.

  • UK

    £50000 - £65000 per annum
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    Unique opportunity to work with one of the world’s leading research-based pharmaceutical company what focuses on human health care with over 11,000 employees worldwide. They are actively looking for a Market Access Manager to join their Global Value & Access department as a Country Market Access Manager. It is a North-London based full-time position offering some flexibility, however they would prefer people to be in the office at least 4 days a week.

    Competitive salary + car allowance + extensive holiday + office tools + bonus and other benefits are included.

    You would be responsible for the overall global strategy for all aspects of Market Access and reimbursement. Strong focus on neurology and oncology with development and launch prospective as well. Ensure maximum access to the company`s products within each Region and Country. Reporting to the Global Market Access Senior Director.

    This is an amazing opportunity for someone with consulting or industry background to work as a Market Access Manager within the Global team.

    Important to have:

    • Understanding and experience of the healthcare reimbursement and health policy
    • Strong health economic understanding
    • Knowledge of government and private payer reimbursement environments
    • HTA experience
    • Relevant subject degree, scientific background is preferred

    This is an amazing opportunity to grow and utilize Market Access knowledge within a global pharmaceutical company. You can work with the most successful neurology drugs today and get involved in new product launches.

    Skills Alliance are the preferred supplier for this role. Please contact Ottilia Molnar for more details on +44/2072206224.

  • UK

    £40000 - £60000 per annum
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    An independent Health Economics consultancy is offering a Senior Consultant position for candidates with strong passion to create quality work in Health Economics. Someone with strong technical skills to design and perform economic evaluations, undertake data analysis projects and support successful HTA submissions.

    The company invests in personal development and offer great opportunities for people with managerial skills. Communication is key, hence they are interested in having the right people in the organisation to fit in their very friendly and pleasant culture. They support you in finding the optimal work-life balance with flexible hours offered. The role can be based in Oxford or London office.

    You would be responsible for helping the team to deliver projects around evidence generation, cost-effectiveness models and budget impact analysis, training junior members on HTA submissions and working on real world data, analysis of trial data.

    Their growing reputation on the field has given the opportunity to work on some of the most innovative therapies and projects. This permanent position is for hands-on individuals who are passionate about Health Economics and want to earn well. The role is offering above the average with excellent benefits.

    Skills Alliance are the only supplier for this role. Please contact Ottilia Molnar for more details on +44/2072206224.

  • €80000 - €100000 per annum, Bonus
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    Skills Alliance is partnered with a MedTech company with a manufacturing plant in Schaffhausen, Switzerland. To reinforce our client’s quality department, Skills Alliance is recruiting for a Quality Engineer.

    In this position, you will implement management and project activities to design and deliver new processes. You will be performing test method validation on current and future equipment and processes. You will apply your knowledge of process control mechanisms and analytical methods for continuous improvement of the quality system and the production line.

    To be considered for this position, you must have a Bachelor’s degree in a related field such as engineering or life sciences and 2 years of past experience with the following:

    – Defining test strategies / Design control
    – Risk assessments and management for process and products improvement (ISO 14971)
    – Design, development and lifecycle management of products or processes
    – Process/Product validation and verification
    – Statistical analysis software
    – Development and implementation of procedures for product & process inspection and testing

    To give you the edge over other candidates, you have the following:

    – 5+ years of experience in the medical device or pharmaceutical industry
    – Master’s Degree in engineering
    – Fluency in German
    – Systems and software validation
    – FDA and customer audits
    – Continuous improvement or a certification in Lean / Six Sigma

    Please contact Khephren Mongongu +41 43 508 29 16 for further information regarding this position or click apply for us to get in contact with you. We are looking forward to receiving your application.

  • UK

    £65000 - £75000 per annum, Benefits
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    Senior Safety Evaluation Physician

    An innovative and patient focused pharma company is recruiting for a Senior Safety Evaluation Physician in the Hertfordshire area.

    This fantastic opportunity will allow you to attend appropriate scientific and medical courses all provided to help advance your skills. Offering an exceptional package consisting of salary, performance-based incentives, top-tier benefits, a comprehensive wellness program, and innovative work-life solutions.

    As Senior Safety Evaluation Physician you will support the Head of Safety Evaluation, the Qualified Person for Pharmacovigilance (EU QPPV) and the global safety community, in the provision of a comprehensive Pharmacovigilance and Product Safety service internationally and in Europe.

    You will also have opportunity for close interactions with other members of the drug safety community, including safety affiliates and the corporate office.

    They require you to hold a UK GMC-approved or similar medical registration and have demonstrated experience in post-registration clinical medicine.

    This role includes but is not limited to leading the response to safety-related medical queries from regulatory authorities, external bodies and internally for specified product

    As General Safety Officer (GSO) for an assigned group of products, you will support the collection, assessment, evaluation, distribution and reporting of individual and cumulative safety reports.

    The Senior Safety Evaluation Physician will have acquired previous experience in pharmacovigilance during which a consistent record of strong contribution has been demonstrated, in addition to success in tackling new challenges and responsibilities.

    This Senior Safety Evaluation Physician opportunity is an office-based position in the Hertfordshire area. A fantastic permanent opportunity with a competitive salary and package.

    Skills Alliance is a preferred supplier for this brilliant opportunity. Please contact Iman Osman for more details on +44 207 220 6220.

    Reference #IOSSEP

  • UK

    £50000 - £60000 per annum, Benefits
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    Senior Manager, Regulatory Affairs, NBG

    An innovative and patient focused pharma company is recruiting for a Senior Manager, Regulatory Affairs (NBG)

    This fantastic opportunity will allow you to lead the development of the Neuroscience Business Group regulatory strategy team. Providing an exceptional package consisting of salary, performance-based incentives, top-tier benefits, a comprehensive wellness program, and innovative work-life solutions.

    As Senior Manager you will be the EU Regulatory Lead for an early phase compound. The Senior Manager will have important input in supporting European regulatory activities for Orphan diseases. You will be involved in supporting European regulatory activities for an innovative rare diseases pipeline. The Senior Manager will have the opportunity to contribute to innovative global regulatory strategies as well as be involved in US regulatory activities.

    Leading the design of clinical development programmes will be an important part of the role. Upcoming submission work will include leading the preparation of an orphan drug application, a PIP and clinical trial applications for Phase 2/3. Close working with US based Global cross-functional Project Teams in the UK, US and Japan will be part of the role. Involvement in post-approval work for Centralised products may also be involved.

    As a Senior Manager, NBG prior experience with EU scientific advice, PIPs and orphan drugs as well as some experience in neurosciences therapy area is desirable. You will need prior experience in the resolution of regulatory risks as well as experience in submissions of CTA/MAA. Life cycle management and interfacing with regulatory authorities. All the above will be part of this diverse and exciting role. The Senior Manager will be influential with the financial budget, matrix and team. Strategic experience and forward thinking, cognitive capabilities as well as great organisational and problem-solving skills are required. A BSc/MSc relevant to the role is desired.

    This Senior Manager NBG Regulatory role is an office-based position in greater London with flexibility. A fantastic permanent opportunity with a competitive salary and package.

    Skills Alliance is a preferred supplier for this brilliant opportunity. Please contact Iman Osman for more details on +44 207 220 6220.

    Reference #IOSMNBG

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    Manager, Regulatory Affairs, NBG

    An innovative and patient focused pharma company is recruiting for a Manager, Regulatory Affairs (NBG)

    This fantastic opportunity will allow you to support the development of the Neuroscience Business Group regulatory strategy team. Providing an exceptional package consisting of salary, performance-based incentives, top-tier benefits, a comprehensive wellness program, and innovative work-life solutions.

    As Manager you will be involved in supporting the European Regulatory activities for an orphan disease pipeline. You will contribute to innovative global regulatory strategies and have opportunities for involvement in US regulatory activities.

    The appointed person will also be the EU Regulatory Lead for an early phase compound, where input to global regulatory strategy including design of clinical development programmes will be an important part of the role. Upcoming submission work will include leading the preparation of an orphan drug application, a PIP and clinical trial applications for Phase 2/3. Close working with US based Global Regulatory Leads and cross-functional Project Teams in the UK, US and Japan will be required for both above. Involvement in post-approval work for Centralised products may also be involved.

    As a Manager, NBG prior experience with EU scientific advice, PIPs and orphan drugs as well as some experience in neuroscience therapy areas is desirable. Experience with EU and/or UK regulatory processes and environment, including clinical trials, Regulatory strategy experience and strong strategic thinking skills are needed. As Manager, NBG you will be liaising and negotiating with regulatory authorities, both verbally and in writing. You must be able to operate in a complex environment and adapt well. You will need prior experience in submissions of CTA/MAA. Life cycle management.

    This is a diverse and exciting role that requires an experienced and forward-thinking individual. Strong organisational and problem-solving skills and a BSc/MSc relevant to the role is desired.

    The Manager, NBG Regulatory role is an office-based position with flexibility. A fantastic permanent opportunity with a competitive salary and package.

    Skills Alliance is a preferred supplier for this brilliant opportunity. Please contact Iman Osman for more details on +44 207 220 6220.

  • UK

    £90000 - £110000 per annum, Benefits
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    Director Regulatory Affairs (New products)

    A fantastic opportunity to join an innovative bio pharmacetical company that is recruiting for a Director (New Products) appointment.

    This positions you as a leading member within a bio pharma which, has had products approved every year since 2016. Providing an exceptional package consisting of salary, stock options and top-tier benefits.
    As Director you will be a key stakeholder in the company’s regulatory activities focusing efforts to obtain worldwide approvals to market products.

    The Director, Regulatory Affairs will manage worldwide interactions and negotiations with regulatory agencies and marketing partners in support of investigational studies, product registrations, and commercial products. Strong leadership skills and strategic implementation is a key focus for this role.

    As Director you will have had experience resolving complex issues in creative and effective ways. Supervising activities that include planning and co-ordination of the writing and reviewing of all regulatory submissions (INDs, IMPDs, CTAs, MAAs, NDAs, BLAs, meeting requests, and briefing documents).

    You will ensure the internal review and submission of these items have been appropriately managed, providing an in-depth reviews of Review of protocols, Investigator Brochures, IND/IMPDs, reports quality, safety, efficacy and labelling) including CTAs, anticipating internal and/or external business challenges and/or regulatory issues will be required.

    As Director you will work with Global Regulatory Lead to support regulatory budget and resource needs for molecule assessing the resource requirement to support molecule strategic objectives.
    You will be xperienced in maintenaning regulatory authorizations in at least one region and experience with supporting a project with development activities in at least two regions is desirable.

    This Director of Regulatory Affairs role is an office-based position based is in the Oxfordshire area. Offering a competitive salary and package.

    Skills Alliance is a preferred supplier for this opportunity. Please contact Iman Osman for more details on +44 207 220 6220.
    #IODNPJ

  • £80000 - £95000 per annum, Benefits
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    Associate Director, Global CMC

    A fantastic opportunity to join an innovative bio pharmacetical company that is recruiting for an Associate Director of Regulatory Affairs, Global CMC.

    The Associate Director position, Global CMC will be responsible for managing, leading registration and providing CMC regulatory support for commercial and development projects worldwide with a bio pharma that has had products approved every year since 2016. Providing an exceptional package consisting of salary, stock options and top-tier benefits.

    As Associate Director, CMC you will be responnsible for the planning and co-ordination of writing and reviewing Module 2 and 3 CTD sections for all regulatory submissions (INDs, IMPDs, CTAs, MAAs, NDAs, BLAs, meeting requests, and briefing documents). You will lead functional/department multi-disciplinary teams in complex, business critical projects to establish Regulatory CMC strategies for commercial products, late and early stage development programs. Solve unique and complex problems that have a broad impact on the function and/or broader department.

    As Associate Director you will provide in-depth reviews of protocols, reports, presentations, and documents, anticipating internal and/or external business challenges and/or regulatory issues
    You will be required to regularly interact with functional leaders and in some cases senior leadership and/or major customers, on matters concerning functional area, business unit or additional business areas., including regulatory agency interactions.

    As Associte Director you will be experienced in identifying and leading for continuous improvement opportunities for the GRA-CMC team and the broader GRA team. In addition to this you must monitor EU and US CMC regulations assessing any changes to ensure all development activities are in compliance with applicable current regulations and guidelines. Experience with electronic Common Technical Document CMC regulatory documents (MAA, BLA, variations, responses and CTAs/INDs). In depth knowledge of FDA, EMA and ICH guidelines is also required.

    This Director of Regulatory Affairs role is an office-based position based is in the Oxfordshire area. Offering a competitive salary and package.

    Skills Alliance is a preferred supplier for this opportunity. Please contact Iman Osman for more details on +44 207 220 6220.
    #IOADCMCJ

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    Senior Manager Regulatory Affairs CMC

    A leading Pharma company specialising in both drugs and medical devices is recruiting for a Senior Manager Regulatory Affairs in Mannheim, Munich or Friedrichsdorf, Germany.

    This is an opportunity to be part of a dynamic and growing Pharma company with a global presence. As they expand there will be excellent scope for progression and development. Providing you with a competitive salary and a dynamic place to work based on trust, self-confidence, and achievement.

    As Senior Manager CMC your role will be to compile and check documentation of module 3, QOS, IMPD, ASMF etc for national and international markets. You will prepare Gap Analysis of pharmaceutical quality dossiers with due diligence. Communicate with authorities as well as supervise the development of projects and marketing authorisation procedures. As Senior Manager CMC you are to compile and review PQRs, coordinate and perform CEP as well as life cycle management processes.

    A diversified and challenging position with cooperating partnership and leeway will be offered. As well as flexible working hours based on trust with continuous development opportunities and a competitive salary provided.

    Skills Alliance is a preferred supplier for this brilliant opportunity. Please contact Iman Osman for more details on +44 207 220 6220.

    Reference #IOSMRAPLG

  • UK

    £90000 - £110000 per annum, Benefits
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    Director Regulatory Affairs

    A fantastic opportunity to join an innovative bio pharmacetical company that is recruiting for a Director (post marketing) appointment.

    This opportunity will position you as a leading member within a bio pharma which, has had products approved every year since 2016. Providing an exceptional package consisting of salary, stock options and top-tier benefits.

    As Director you will be a key stakeholder in the company’s regulatory activities and oversee the activities of product development and life cycle management for established products. You will be liasing with authorites globally to market products. As Director of Regulatory Affairs you will manage worldwide interactions and negotiations with stakeholders, agencies and partners to ensure continuity of supply. Strong leadership and strategic implementation is a key focus for this role.

    You will be responsible for managing partnerships from a regulatory standpoint for products/projects and the review and approval of labelling for the company’s products. You must have strong experience with documentation in support of commercial products (I.e. clinical protocols/CSRs and investigator brochures, quality, nonclinical, safety) and ensure the timely preparation, review, and submission of investigational and product submissions such as INDs/CTAs/IMPDs, MAAs/BLAs/NDAs and variations for products/projects.

    As Director you will oversee direct reports in preparation and management of above responsibilities and assist as needed. This exciting role requires you to have a deep and broad knowledge of regulatory affairs and direct experience with biological and/or pharmaceutical regulatory submissions and product approvals. You must have a proven track record of effective collaboration with regulatory agencies knowledge and experience in preparation of investigational and new product submissions with EU, US, and ex-US countries including eCTD format as well as experience in preparation of global regulatory strategies

    A proven record of maintenance of regulatory authorizations and variations in at least two regions and supporting a project with development activities in at least two regions is desirable.

    This Director of Regulatory Affairs role is an office-based position based is in the Oxfordshire area. Offering a competitive salary and package.

    Skills Alliance is a preferred supplier for this opportunity. Please contact Iman Osman for more details on +44 207 220 6220.
    #IODPMJ

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    Senior Manager, Regulatory Affairs

    An innovative and patient focused pharma company is recruiting for a Senior Manager, Regulatory Affairs, Growth Markets in the Hertfordshire area.

    This fantastic opportunity will allow you to attend appropriate scientific and medical courses all provided to help advance your skills. Offering an exceptional package consisting of salary, performance-based incentives, top-tier benefits, a comprehensive wellness program, and innovative work-life solutions.

    As Senior manager of growth markets you will apply broad knowledge and interpretation of regulatory requirements in growth markets for the company products to the drug development process. This includes the promulgation of health authority marketing dossiers to enable efficient registration of medicinal products consistent with the supported regions commericial objectives. As manager you will ensure that regulatory documentation meets relevant regulatory requirments and quality standards.

    You will also have opportunity to direct the activity of a work team project within the department and may have responsibility for management of highly skilled professional employees.

    The Senior manager of growth markets opportunity is an office-based position in the Hertfordshire area. A fantastic permanent opportunity with a competitive salary and package.

    Skills Alliance is a preferred supplier for this brilliant opportunity. Please contact Iman Osman for more details on +44 207 220 6220.

    Reference #IOSMGME

  • £30000 - £40000 per annum, Benefits
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    An exciting medical device start-up is recruiting for a Regulatory Analyst to join an award-winning and ambitious start-up.

    The medical device start-up is developing “magnetic blood filtration”, a revolutionary treatment for blood-borne diseases which removes pathogens directly from the bloodstream. The technology is like dialysis, circulating a patient’s blood through an external loop to remove disease causing targets. While dialysis relies on non-specific size-based filtration. This process uses magnetic particles coated with antibodies to target specific components, and magnetic forces to extract them.

    Your role
    As Regulatory Analyst, you will assist in drafting the company’s regulatory documentation, managing Technical Files and Quality Management Systems. You will work directly with the technical team and highly experienced Quality and Regulatory Director to help bring each product through the medical device regulatory pathway. This is an exciting opportunity to join an award-winning, ambitious start-up in which you can have a real impact during an exciting stage of development. In addition to a competitive salary, the company operates a stock option plan for its employees. The post is a full-time, permanent appointment, subject to a performance-based probation period of 6 months. The place of work will be in the company’s offices in London.

    Experience and Attributes
    You should have a Bachelors or Masters degree in Regulatory Affairs or a related area and at least 2 years relevant experience in industry. Excellent written communication skills, a high level of organisation and keen eye for detail ie required. In addition, you should have the following skills and attributes:

    • Good knowledge of EU Medical Device Regulations, including difference between MDD and MDR.
    • Understanding of EU regulatory pathway for Class II and Class III medical devices, including required tests and data to secure a CE mark.
    • Good knowledge of relevant ISO standards (e.g. 10993, 14971…).
    • Experience setting up and/or working under ISO 13485 approved QMS system.
    • Experience writing regulatory documentation, including risk assessments, technical files and design history files.
    • Ability to work independently to manage and prioritise workload and work collaboratively as part of a team.
    • Self-motivated, pro-active, innovative, enthusiastic and personable.

    This is a great position offering a competitive salary and benefits. It is an office-based role located in London.

    Skills Alliance is a preferred supplier for this brilliant opportunity. Please contact Iman Osman for more details on +44 207 220 6220.

    Reference #IORAM

  • £90000 - £110000 per annum, Benefits
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    Director, Regulatory Affairs

    A global biopharmaceutical company developing life-changing medicines is recruiting for a Director of Regulatory Affairs in Oxford, United Kingdom.

    This is an opportunity to be a key stakeholder in the companies’ Regulatory activities. This global biopharmaceutical is passionate about developing meaningful medicines, bringing them to people with unaddressed needs around the world. As Director you will play a key role in seeking solutions for rare or complex diseases, and ensuring solutions are available for the often-overlooked patients in need.

    As Director your role will be to initiative and oversee regulatory activities of product development and life cycle management for licensed products. You will support the company’s efforts to obtain and maintain agreements with Health Authorities globally to market products. The Director of Regulatory Affairs will manage worldwide interactions and negotiations with regulatory agencies, internal stakeholders, and partners in support of product registrations and continuity of supply. As a key member you may also be leading project teams while also overseeing junior regulatory team members.

    Essential Functions

    • Manage partnerships from regulatory standpoint for products/projects
    • Review and approve labelling for the company’s products
    • Review documentation in support of commercial product (I.e. clinical protocols/CSRs and investigator brochures, quality, nonclinical, safety)
    • Ensure the timely preparation, review, and submission of investigational and product submissions such as INDs/CTAs/IMPDs, MAAs/BLAs/NDAs and variations for products/projects

    Required Knowledge, Skills, and Abilities

    • Deep and broad knowledge of regulatory affairs and requirements; direct experience with biological and/or pharmaceutical regulatory submissions and product approvals
    • Knowledge and experience in preparation of investigational and new product submissions with EU, US, and ex-US countries including eCTD format
    • Experience in preparation of global regulatory strategies
    • Experience with maintenance of regulatory authorizations and variations in at least two regions
    • Experience with supporting a project with development activities in at least two regions
    • Evaluative, analytical and interpretative skills enabling review and synthesis of reports and other documents used in regulatory planning and submissions

    Bachelors or Masters or advanced degree in a scientific discipline, with a proven track record of increasingly responsible regulatory experience in the pharmaceutical and/or biotech industry is desirable.

    As Director you will be provided with an incredibly competitive salary and flexible home/office based working hours.

    Skills Alliance is a preferred supplier for this brilliant opportunity. Please contact Iman Osman for more details on +44 207 220 6220.

    Reference #IODJ

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    The Deputy EU QPPV and Deputy Head of Drug Safety International

    A Global, patient dedicated Bio-tech with a robust gene therapy pipeline is seeking The Deputy EU QPPV and Deputy Head of Drug Safety International.

    The Deputy EU QPPV and Deputy Head of Drug Safety International will support the implementation and management of the global pharmacovigilance system, including safety assessments and surveillance, compliant, timely and complete regulatory authority reporting, benefit-risk assessments, risk identification and mitigation management and communication of safety information. You will be required to serve as an expert to internal staff across various Departments within the company (Clinical Research, Medical Affairs, Clinical Operations, Regulatory Affairs, Data Management, Statistics, Quality Assurance) leading the provision of key clinical, operational, and strategic input around safety matters, as well as knowledge of a given product’s drug safety profile.

    Education

    • M.D Degree
    • Minimum of 4 years of clinical experience as a practicing physician
    • Minimum of 7-10years pharmacovigilance drug safety experience including benefit/ risk analysis and safety evaluations
    • Minimum of 3 years’ experience as EU QPPV

    Previous Experience and Skills

    • Expert knowledge of EU GVP, FDA regulations, ICH guidelines, and other applicable regulatory guidance documents required
    • Experience with pharmacovigilance audit and regulatory inspection processes.
    • Ability to write SOPs and other working practices and documents within the context of clinical and post-marketing drug safety reporting
    • Familiarity with common adverse event management databases (e.g. Argus)
    • Knowledge of MedDRA and WHO Drug coding dictionaries
    • Excellent clinical judgment and ability to communicate complex clinical issues in a scientifically sound and understandable way Comprehensive experience with obtaining, analysing, disseminating, and reporting safety information in compliance with safety regulations, including periodic safety reports
    • Prior experience in interactions with regulatory authorities on drug safety aspects as well as risk management strategies and pharmaco-epidemiology
    • Prior experience with MHRA and other EMA drive PV systems inspections, and preferably also with FDA PV inspections

    The Deputy EU QPPV and Deputy Head of Drug Safety position will be based in the EU at one of International offices, with Amsterdam being a preference. This is a fantastic permanent opportunity offering a highly competitive salary and package.

    Skills Alliance is a preferred supplier for this opportunity. Please contact Iman Osman for more details on +44 207 220 6220.

    #IOEUQPPVA

  • £65000 - £75000 per annum, + Benefits
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    Global Labelling, Associate Director

    A fantastic opportunity to join an innovative pharma company that is recruiting for an Associate Director for Global Labelling.

    This opportunity will allow for collaborative input making a real difference in the lives of patients and the life sciences. Providing an exceptional package consisting of salary, performance-based incentives, top-tier benefits, a comprehensive wellness program, and innovative work-life solutions.

    You will be responsible for the packaging and labelling of pharmaceutical products in accordance with regulations; principally the information printed on the outward packaging and inner leaflet, containing important safety information and any adverse effects.

    Typical day-to-day responsibilities will be authoring PILs and SmPCs. You will also be responsible for updating label information according to health authorities, reviewing documentation and updating the company’s core data sheet.

    They require an experienced professional with Regulatory and Health Authority experience. You will need to understand the artwork, labelling, submissions and variations for different markets. Line management may be required at a later stage. Medical writers are also encouraged to apply. The company is open to an individual with strong knowledge in the area who is looking for the next step in their career.

    This Associate Director of Global Labelling is an office-based position within greater London. This is a fantastic permanent opportunity offering a competitive salary and package.
    Skills Alliance is a preferred supplier for this opportunity. Please contact Iman Osman for more details on +44 207 220 6220.
    #IOGLADE

  • £30000 - £45000 per annum, car allowance
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    I am partnered with a small growing CRO who are seeking an experienced CRA to join their growing team. This is a unique opportunity to get involved in project management tasks such as ethics submissions, contract negotiations and attending bid defence meetings. This is a quality driven environment meaning CRAs are not over burdened with too many protocols and site visits.

    The company also offer extensive training and career development into Project Management.

    Responsibilities:

    • Responsible for routine site visits
    • Start up activities
    • Mentoring and training of CRAs

    Experience:

    • 18 months + independent monitoring experience
    • Experience working in complex therapy areas
    • Scientific degree or equivalent

    For more information please call Troy Neenan on 02072206237 or click apply.

  • £65 - £90 per hour
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    Innovative Rare Disease Biotech Company

    Support implementation and management of the global pharmacovigilance system, including safety assessments and surveillance, risk identification and mitigation management, and communication of safety information.

    Expert knowledge of EU GVP, FDA regulations, ICH guidelines, and other applicable regulatory guidance documents required

    Experience with pharmacovigilance audit and regulatory inspection processes.

    Ability to write SOPs and other working practices and documents within the context of clinical and post-marketing drug safety reporting

  • UK

    £40000 - £48000 per annum, car allowance and bonus
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    I am partnered with mid-sized Pharma company specialising in Neuroscience who are seeking a Junior Study Manager to join their growing team. This is a great opportunity for an experienced CRA to join move away from monitoring and into project management.

    You will be responsible for coordinating phase III studies whilst also managing a small-scale study. The Junior Study Manager role will also encompass vendor management of the CRO.

    Experience:

    • 3 years independent monitoring experience within CRO or Pharma.
    • Experience working in complex therapy areas.
    • Experience coordinating studies advantageous

    For more info please contact Troy Neenan on 02072206237.

  • UK

    £40000 - £48000 per annum, car allowance and bonus
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    Share

    I am partnered with mid-sized Pharma company specialising in Neuroscience who are seeking a Junior Study Manager to join their growing team. This is a great opportunity for an experienced CRA to join move away from monitoring and into project management.

    You will be responsible for coordinating phase III studies whilst also managing a small-scale study. The Junior Study Manager role will also encompass vendor management of the CRO.

    Experience:

    • 3 years independent monitoring experience within CRO or Pharma.
    • Experience working in complex therapy areas.
    • Experience coordinating studies advantageous

    For more info please contact Troy Neenan on 02072206237.

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    The Deputy EU QPPV and Deputy Head of Drug Safety International

    A Global, patient dedicated Bio-tech with a robust gene therapy pipeline is seeking The Deputy EU QPPV and Deputy Head of Drug Safety International.

    The Deputy EU QPPV and Deputy Head of Drug Safety International will support the implementation and management of the global pharmacovigilance system, including safety assessments and surveillance, compliant, timely and complete regulatory authority reporting, benefit-risk assessments, risk identification and mitigation management and communication of safety information. You will be required to serve as an expert to internal staff across various Departments within the company (Clinical Research, Medical Affairs, Clinical Operations, Regulatory Affairs, Data Management, Statistics, Quality Assurance) leading the provision of key clinical, operational, and strategic input around safety matters, as well as knowledge of a given product’s drug safety profile.

    Education

    • M.D Degree
    • Minimum of 4 years of clinical experience as a practicing physician
    • Minimum of 7-10years pharmacovigilance drug safety experience including benefit/ risk analysis and safety evaluations
    • Minimum of 3 years’ experience as EU QPPV

    Previous Experience and Skills

    • Expert knowledge of EU GVP, FDA regulations, ICH guidelines, and other applicable regulatory guidance documents required
    • Experience with pharmacovigilance audit and regulatory inspection processes.
    • Ability to write SOPs and other working practices and documents within the context of clinical and post-marketing drug safety reporting
    • Familiarity with common adverse event management databases (e.g. Argus)
    • Knowledge of MedDRA and WHO Drug coding dictionaries
    • Excellent clinical judgment and ability to communicate complex clinical issues in a scientifically sound and understandable way Comprehensive experience with obtaining, analysing, disseminating, and reporting safety information in compliance with safety regulations, including periodic safety reports
    • Prior experience in interactions with regulatory authorities on drug safety aspects as well as risk management strategies and pharmaco-epidemiology
    • Prior experience with MHRA and other EMA drive PV systems inspections, and preferably also with FDA PV inspections

    The Deputy EU QPPV and Deputy Head of Drug Safety position will be based in the EU at one of International offices, with Amsterdam being a preference. This is a fantastic permanent opportunity offering a highly competitive salary and package.

    Skills Alliance is a preferred supplier for this opportunity. Please contact Iman Osman for more details on +44 207 220 6220.

    #IOEUQPPVA

  • £90000 - £110000 per annum, Benefits
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    Director, Regulatory Affairs

    A global biopharmaceutical company developing life-changing medicines is recruiting for a Director of Regulatory Affairs in Oxford, United Kingdom.

    This is an opportunity to be a key stakeholder in the companies’ Regulatory activities. This global biopharmaceutical is passionate about developing meaningful medicines, bringing them to people with unaddressed needs around the world. As Director you will play a key role in seeking solutions for rare or complex diseases, and ensuring solutions are available for the often-overlooked patients in need.

    As Director your role will be to initiative and oversee regulatory activities of product development and life cycle management for licensed products. You will support the company’s efforts to obtain and maintain agreements with Health Authorities globally to market products. The Director of Regulatory Affairs will manage worldwide interactions and negotiations with regulatory agencies, internal stakeholders, and partners in support of product registrations and continuity of supply. As a key member you may also be leading project teams while also overseeing junior regulatory team members.

    Essential Functions

    • Manage partnerships from regulatory standpoint for products/projects
    • Review and approve labelling for the company’s products
    • Review documentation in support of commercial product (I.e. clinical protocols/CSRs and investigator brochures, quality, nonclinical, safety)
    • Ensure the timely preparation, review, and submission of investigational and product submissions such as INDs/CTAs/IMPDs, MAAs/BLAs/NDAs and variations for products/projects

    Required Knowledge, Skills, and Abilities

    • Deep and broad knowledge of regulatory affairs and requirements; direct experience with biological and/or pharmaceutical regulatory submissions and product approvals
    • Knowledge and experience in preparation of investigational and new product submissions with EU, US, and ex-US countries including eCTD format
    • Experience in preparation of global regulatory strategies
    • Experience with maintenance of regulatory authorizations and variations in at least two regions
    • Experience with supporting a project with development activities in at least two regions
    • Evaluative, analytical and interpretative skills enabling review and synthesis of reports and other documents used in regulatory planning and submissions

    Bachelors or Masters or advanced degree in a scientific discipline, with a proven track record of increasingly responsible regulatory experience in the pharmaceutical and/or biotech industry is desirable.

    As Director you will be provided with an incredibly competitive salary and flexible home/office based working hours.

    Skills Alliance is a preferred supplier for this brilliant opportunity. Please contact Iman Osman for more details on +44 207 220 6220.

    Reference #IODJ

  • £65000 - £75000 per annum, + Benefits
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    Global Labelling, Associate Director

    A fantastic opportunity to join an innovative pharma company that is recruiting for an Associate Director for Global Labelling.

    This opportunity will allow for collaborative input making a real difference in the lives of patients and the life sciences. Providing an exceptional package consisting of salary, performance-based incentives, top-tier benefits, a comprehensive wellness program, and innovative work-life solutions.

    You will be responsible for the packaging and labelling of pharmaceutical products in accordance with regulations; principally the information printed on the outward packaging and inner leaflet, containing important safety information and any adverse effects.

    Typical day-to-day responsibilities will be authoring PILs and SmPCs. You will also be responsible for updating label information according to health authorities, reviewing documentation and updating the company’s core data sheet.

    They require an experienced professional with Regulatory and Health Authority experience. You will need to understand the artwork, labelling, submissions and variations for different markets. Line management may be required at a later stage. Medical writers are also encouraged to apply. The company is open to an individual with strong knowledge in the area who is looking for the next step in their career.

    This Associate Director of Global Labelling is an office-based position within greater London. This is a fantastic permanent opportunity offering a competitive salary and package.
    Skills Alliance is a preferred supplier for this opportunity. Please contact Iman Osman for more details on +44 207 220 6220.
    #IOGLADE

  • UK

    £65000 - £75000 per annum, Benefits
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    Senior Safety Evaluation Physician

    An innovative and patient focused pharma company is recruiting for a Senior Safety Evaluation Physician in the Hertfordshire area.

    This fantastic opportunity will allow you to attend appropriate scientific and medical courses all provided to help advance your skills. Offering an exceptional package consisting of salary, performance-based incentives, top-tier benefits, a comprehensive wellness program, and innovative work-life solutions.

    As Senior Safety Evaluation Physician you will support the Head of Safety Evaluation, the Qualified Person for Pharmacovigilance (EU QPPV) and the global safety community, in the provision of a comprehensive Pharmacovigilance and Product Safety service internationally and in Europe.

    You will also have opportunity for close interactions with other members of the drug safety community, including safety affiliates and the corporate office.

    They require you to hold a UK GMC-approved or similar medical registration and have demonstrated experience in post-registration clinical medicine.

    This role includes but is not limited to leading the response to safety-related medical queries from regulatory authorities, external bodies and internally for specified product

    As General Safety Officer (GSO) for an assigned group of products, you will support the collection, assessment, evaluation, distribution and reporting of individual and cumulative safety reports.

    The Senior Safety Evaluation Physician will have acquired previous experience in pharmacovigilance during which a consistent record of strong contribution has been demonstrated, in addition to success in tackling new challenges and responsibilities.

    This Senior Safety Evaluation Physician opportunity is an office-based position in the Hertfordshire area. A fantastic permanent opportunity with a competitive salary and package.

    Skills Alliance is a preferred supplier for this brilliant opportunity. Please contact Iman Osman for more details on +44 207 220 6220.

    Reference #IOSSEP

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    Senior Manager, Regulatory Affairs

    An innovative and patient focused pharma company is recruiting for a Senior Manager, Regulatory Affairs, Growth Markets in the Hertfordshire area.

    This fantastic opportunity will allow you to attend appropriate scientific and medical courses all provided to help advance your skills. Offering an exceptional package consisting of salary, performance-based incentives, top-tier benefits, a comprehensive wellness program, and innovative work-life solutions.

    As Senior manager of growth markets you will apply broad knowledge and interpretation of regulatory requirements in growth markets for the company products to the drug development process. This includes the promulgation of health authority marketing dossiers to enable efficient registration of medicinal products consistent with the supported regions commericial objectives. As manager you will ensure that regulatory documentation meets relevant regulatory requirments and quality standards.

    You will also have opportunity to direct the activity of a work team project within the department and may have responsibility for management of highly skilled professional employees.

    The Senior manager of growth markets opportunity is an office-based position in the Hertfordshire area. A fantastic permanent opportunity with a competitive salary and package.

    Skills Alliance is a preferred supplier for this brilliant opportunity. Please contact Iman Osman for more details on +44 207 220 6220.

    Reference #IOSMGME

  • UK

    £90000 - £110000 per annum, Benefits
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    Director Regulatory Affairs

    A fantastic opportunity to join an innovative bio pharmacetical company that is recruiting for a Director (post marketing) appointment.

    This opportunity will position you as a leading member within a bio pharma which, has had products approved every year since 2016. Providing an exceptional package consisting of salary, stock options and top-tier benefits.

    As Director you will be a key stakeholder in the company’s regulatory activities and oversee the activities of product development and life cycle management for established products. You will be liasing with authorites globally to market products. As Director of Regulatory Affairs you will manage worldwide interactions and negotiations with stakeholders, agencies and partners to ensure continuity of supply. Strong leadership and strategic implementation is a key focus for this role.

    You will be responsible for managing partnerships from a regulatory standpoint for products/projects and the review and approval of labelling for the company’s products. You must have strong experience with documentation in support of commercial products (I.e. clinical protocols/CSRs and investigator brochures, quality, nonclinical, safety) and ensure the timely preparation, review, and submission of investigational and product submissions such as INDs/CTAs/IMPDs, MAAs/BLAs/NDAs and variations for products/projects.

    As Director you will oversee direct reports in preparation and management of above responsibilities and assist as needed. This exciting role requires you to have a deep and broad knowledge of regulatory affairs and direct experience with biological and/or pharmaceutical regulatory submissions and product approvals. You must have a proven track record of effective collaboration with regulatory agencies knowledge and experience in preparation of investigational and new product submissions with EU, US, and ex-US countries including eCTD format as well as experience in preparation of global regulatory strategies

    A proven record of maintenance of regulatory authorizations and variations in at least two regions and supporting a project with development activities in at least two regions is desirable.

    This Director of Regulatory Affairs role is an office-based position based is in the Oxfordshire area. Offering a competitive salary and package.

    Skills Alliance is a preferred supplier for this opportunity. Please contact Iman Osman for more details on +44 207 220 6220.
    #IODPMJ

  • £30000 - £40000 per annum, Benefits
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    An exciting medical device start-up is recruiting for a Regulatory Analyst to join an award-winning and ambitious start-up.

    The medical device start-up is developing “magnetic blood filtration”, a revolutionary treatment for blood-borne diseases which removes pathogens directly from the bloodstream. The technology is like dialysis, circulating a patient’s blood through an external loop to remove disease causing targets. While dialysis relies on non-specific size-based filtration. This process uses magnetic particles coated with antibodies to target specific components, and magnetic forces to extract them.

    Your role
    As Regulatory Analyst, you will assist in drafting the company’s regulatory documentation, managing Technical Files and Quality Management Systems. You will work directly with the technical team and highly experienced Quality and Regulatory Director to help bring each product through the medical device regulatory pathway. This is an exciting opportunity to join an award-winning, ambitious start-up in which you can have a real impact during an exciting stage of development. In addition to a competitive salary, the company operates a stock option plan for its employees. The post is a full-time, permanent appointment, subject to a performance-based probation period of 6 months. The place of work will be in the company’s offices in London.

    Experience and Attributes
    You should have a Bachelors or Masters degree in Regulatory Affairs or a related area and at least 2 years relevant experience in industry. Excellent written communication skills, a high level of organisation and keen eye for detail ie required. In addition, you should have the following skills and attributes:

    • Good knowledge of EU Medical Device Regulations, including difference between MDD and MDR.
    • Understanding of EU regulatory pathway for Class II and Class III medical devices, including required tests and data to secure a CE mark.
    • Good knowledge of relevant ISO standards (e.g. 10993, 14971…).
    • Experience setting up and/or working under ISO 13485 approved QMS system.
    • Experience writing regulatory documentation, including risk assessments, technical files and design history files.
    • Ability to work independently to manage and prioritise workload and work collaboratively as part of a team.
    • Self-motivated, pro-active, innovative, enthusiastic and personable.

    This is a great position offering a competitive salary and benefits. It is an office-based role located in London.

    Skills Alliance is a preferred supplier for this brilliant opportunity. Please contact Iman Osman for more details on +44 207 220 6220.

    Reference #IORAM

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    Manager, Regulatory Affairs, NBG

    An innovative and patient focused pharma company is recruiting for a Manager, Regulatory Affairs (NBG)

    This fantastic opportunity will allow you to support the development of the Neuroscience Business Group regulatory strategy team. Providing an exceptional package consisting of salary, performance-based incentives, top-tier benefits, a comprehensive wellness program, and innovative work-life solutions.

    As Manager you will be involved in supporting the European Regulatory activities for an orphan disease pipeline. You will contribute to innovative global regulatory strategies and have opportunities for involvement in US regulatory activities.

    The appointed person will also be the EU Regulatory Lead for an early phase compound, where input to global regulatory strategy including design of clinical development programmes will be an important part of the role. Upcoming submission work will include leading the preparation of an orphan drug application, a PIP and clinical trial applications for Phase 2/3. Close working with US based Global Regulatory Leads and cross-functional Project Teams in the UK, US and Japan will be required for both above. Involvement in post-approval work for Centralised products may also be involved.

    As a Manager, NBG prior experience with EU scientific advice, PIPs and orphan drugs as well as some experience in neuroscience therapy areas is desirable. Experience with EU and/or UK regulatory processes and environment, including clinical trials, Regulatory strategy experience and strong strategic thinking skills are needed. As Manager, NBG you will be liaising and negotiating with regulatory authorities, both verbally and in writing. You must be able to operate in a complex environment and adapt well. You will need prior experience in submissions of CTA/MAA. Life cycle management.

    This is a diverse and exciting role that requires an experienced and forward-thinking individual. Strong organisational and problem-solving skills and a BSc/MSc relevant to the role is desired.

    The Manager, NBG Regulatory role is an office-based position with flexibility. A fantastic permanent opportunity with a competitive salary and package.

    Skills Alliance is a preferred supplier for this brilliant opportunity. Please contact Iman Osman for more details on +44 207 220 6220.

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    Senior Manager Regulatory Affairs CMC

    A leading Pharma company specialising in both drugs and medical devices is recruiting for a Senior Manager Regulatory Affairs in Mannheim, Munich or Friedrichsdorf, Germany.

    This is an opportunity to be part of a dynamic and growing Pharma company with a global presence. As they expand there will be excellent scope for progression and development. Providing you with a competitive salary and a dynamic place to work based on trust, self-confidence, and achievement.

    As Senior Manager CMC your role will be to compile and check documentation of module 3, QOS, IMPD, ASMF etc for national and international markets. You will prepare Gap Analysis of pharmaceutical quality dossiers with due diligence. Communicate with authorities as well as supervise the development of projects and marketing authorisation procedures. As Senior Manager CMC you are to compile and review PQRs, coordinate and perform CEP as well as life cycle management processes.

    A diversified and challenging position with cooperating partnership and leeway will be offered. As well as flexible working hours based on trust with continuous development opportunities and a competitive salary provided.

    Skills Alliance is a preferred supplier for this brilliant opportunity. Please contact Iman Osman for more details on +44 207 220 6220.

    Reference #IOSMRAPLG

  • UK

    £50000 - £60000 per annum, Benefits
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    Senior Manager, Regulatory Affairs, NBG

    An innovative and patient focused pharma company is recruiting for a Senior Manager, Regulatory Affairs (NBG)

    This fantastic opportunity will allow you to lead the development of the Neuroscience Business Group regulatory strategy team. Providing an exceptional package consisting of salary, performance-based incentives, top-tier benefits, a comprehensive wellness program, and innovative work-life solutions.

    As Senior Manager you will be the EU Regulatory Lead for an early phase compound. The Senior Manager will have important input in supporting European regulatory activities for Orphan diseases. You will be involved in supporting European regulatory activities for an innovative rare diseases pipeline. The Senior Manager will have the opportunity to contribute to innovative global regulatory strategies as well as be involved in US regulatory activities.

    Leading the design of clinical development programmes will be an important part of the role. Upcoming submission work will include leading the preparation of an orphan drug application, a PIP and clinical trial applications for Phase 2/3. Close working with US based Global cross-functional Project Teams in the UK, US and Japan will be part of the role. Involvement in post-approval work for Centralised products may also be involved.

    As a Senior Manager, NBG prior experience with EU scientific advice, PIPs and orphan drugs as well as some experience in neurosciences therapy area is desirable. You will need prior experience in the resolution of regulatory risks as well as experience in submissions of CTA/MAA. Life cycle management and interfacing with regulatory authorities. All the above will be part of this diverse and exciting role. The Senior Manager will be influential with the financial budget, matrix and team. Strategic experience and forward thinking, cognitive capabilities as well as great organisational and problem-solving skills are required. A BSc/MSc relevant to the role is desired.

    This Senior Manager NBG Regulatory role is an office-based position in greater London with flexibility. A fantastic permanent opportunity with a competitive salary and package.

    Skills Alliance is a preferred supplier for this brilliant opportunity. Please contact Iman Osman for more details on +44 207 220 6220.

    Reference #IOSMNBG

  • USA

    $115000 - $130000 per annum
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    A globally known specialty pharmaceutical company in Richmond, VA is looking for PV Quality Audit Manager to join their company full time. Being a leader in the addiction/ pain management space they are fostering a culture of innovation and pioneering that better supports evidence- based treatments for addictions.

    The following key responsibilities of this role are to support strategic risk-based audit programs using a formal Risk Assessment Tool. Maintain consistent updates of the risk assessment tool for both internal and external processes. Publish approved audit plans to relevant departments internally. Create and maintain a Master List of approved PV providers alongside the Medical Compliance Manager to assess the risk of service carried out on behalf of the company.

    Qualifications:

    • Must be able to be on-site (great relocation package if you’re not currently in the Richmond, VA area)
    • Ability to travel regionally and internationally (20-40%)
    • Relevant degree in life science
    • Experience with Quality System auditing
    • Deep understanding of regulatory requirements and guidance that are relevant to PV (i.e Directives, publications ICH guidance)

    For more information please contact alex.f.a4lgdx1grj7e@skillsalliance.aptrack.co

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    Unser Klient ist eins der grössten Unternehmen in Deutschland. Das Krankenhaus ist ein Maximalversorger mit modernste Medizin und mit einen Platz wo Patienten schnell wieder gesund sind.

    Das Haus arbeitet interdisziplinär mit dem Viszeral-onkologisches Zentrum sowie mit der Viszeralchirurgie und bietet u.a. die folgenden Leistungen an:

    • Diagnostische und therapeutische Endoskopie
    • Gastroenterologie
    • Sonografie
    • Innere Medizin und Infektiologie
    • Funktionsdiagnostik

    Wir suchen einen Kandidaten mit dem Profil:

    • FA für Innere Medizin mit Schwerpunkt Gastroenterologie
    • Solider klinischer und internistischer Erfahrung
    • Gute Kenntnisse in der interventionellen Endoskopie
    • Gute Kenntnisse in der Sonographie ist von Vorteil

    Ihre Aufgaben:

    • Betreuung der Patienten auf der gastroenterologischen Station
    • Betreuung von Patienten mit gastroenterologischen Fragestellungen des ganzen Hauses im Zentrum für Ultraschalldiagnostik und interventionelle Endoskopie
    • Teilnahme am Endoskopie-Rufdienst wird vorausgesetz

    Ihre Vorteile:

    • Ausssertarifliche Vergütung
    • Finanzierte (Digitale-) Fort- und Weiterbildungsmöglichkeiten
    • Zusatzversicherung mit Wahl/- Chefarztbehandlung und Wahlleistung
    • Kinderbetreuungsmöglichkeiten (eigene oder koop. KiTa)
    • Betriebliches Gesundheitsmanagement

    Sollte diese Stelle für Sie von Interesse sein, dann freuen wir uns auf ihre Kontaktaufnahme bei Frau Jessica Demirtas, Recruitment & Consultant DACH: Tel. 0041 43 508 73 11 oder per E-Mail: jessica.d.a4lgdx1grj9y@SkillsAlliance.aptrack.co

  • €350 - €600 per day
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    Senior Medical Science Liaison

    A Medical Science Liaison position has become available with a reputatble Global Pharma company. The role is well suited to someone with 1.5 years+ previous MSL experience.

    Potential to extend / move into a permanent role

    Oncology

    Please apply for further details.

  • £65000 - £75000 per annum, bonus + benefits
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    A very rare opportunity for an experienced (Senior) Study Manager or (Senior) Trial Manager to join an exciting niche start-up Biopharma, this position is permanent and office-based in London.

    This position is with a start-up and niche Biotech focussed in Oncology and will offer very exciting long-term prospects. This is quite a unique opportunity to join the company at early stages so there will be a lot of exposure. They work in exciting and innovative therapy areas.

    The Senior Clinical Trial Manager role is a great opportunity for Study Manager to work in a wide ranging study management role, they would prefer someone who has worked closely with data management. They require a strong project management management experience from Pharma or Biotech and Oncology. This would be working on early phase trials.

    This is a permanent and full-time position. It is office-based in London offering around GBP 65-75K depending on experience + bonus + benefits.

    Skills Alliance are the exclusive partner for this role, please contact Mark Anderson for more details +44 207 220 6209 or click APPLY NOW!

  • £60000 - £75000 per annum, excellent package + equity
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    A very exciting opportunity to join a fast growing Biotech. Permanent Clinical Study Manager or Senior Clinical Study Manager role based in Oxfordshire offering an excellent salary and package.

    This exciting and innovative Biotech company are at early stages with trials working in a range of disease areas in advanced therapies. They will be expanding and will offer great long-term prospects. The company are looking for an experienced Study Manager to join the team, this would be working on interesting early phase studies in Fibrosis.

    This is a full-time and permanent position. It is office-based in Oxfordshire with flexibility to work from home for the right candidate. They offer an excellent salary and package around GBP 60-75K depending on experience + bonus + equity + extensive benefits.

    Skills Alliance are the exclusive partner for this Senior Clinical Study Manager / Senior Clinical Trial Manager position. For more details please call Mark Anderson on 0207 220 6209 or click apply now.

  • £65000 - £75000 per annum, excellent package
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    A very exciting opportunity to join a fast growing Biotech. Permanent Senior Clinical Trial Manager or Senior Clinical Study Manager role based in Hertfordshire offering an excellent salary and package.

    This exciting and innovative Biotech company are at early stages with trials working in advanced therapies. They will be expanding and will offer great long-term prospects. The company are looking for an experienced Senior Study Manager, this would be working on interesting early phase studies. They require a strong clinical trial management background, ideally experience in early phase, complex TAs and ideally program level experience. It would be overseeing one of their two programs.

    This is a full-time and permanent position. It is office-based in Hertfordshire with flexibility to work from home. They offer an excellent salary and package around GBP 65-70K depending on experience + bonus + extensive benefits.

    Skills Alliance are the preferred supplier for this CPM / Senior CPM position. For more details please call Mark Anderson on 0207 220 6209 or click apply now.

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    A very rare opportunity for an experienced Program Director to join an exciting niche start-up Biopharma, this position is permanent and office-based in London.

    This position is with a start-up and niche Biotech focussed in Oncology and will offer very exciting long-term prospects. This is quite a unique opportunity to join the company at early stages so there will be a lot of exposure. They work in exciting and innovative therapy areas.

    The role spans across pre-clinical through to clinical trials specifically in Oncology. They need a very experienced individual who is also happy to do hands on work. This is a very cross-functional role with oversight of an asset/compound.

    This is a permanent and full-time position. It is office-based in London offering an excellent salary + bonus + benefits (over £100K package).

    Skills Alliance are the exclusive partner for this role, please contact Mark Anderson for more details +44 207 220 6209 or click APPLY NOW!

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    You are currently registered and logged onto our site and this form is therefore using the personal details and CV you have saved with your profile. You can amend them here but they won't overwrite your saved account details. The new uploaded CV and/or cover letter will be saved onto your account if it is not exceeding the maximum of 5 documents.

    Before applying for this position you need to submit your online CV. Click the button below to continue.


    Share

    A very rare opportunity for an experienced Program Director to join an exciting niche start-up Biopharma, this position is permanent and office-based in London.

    This position is with a start-up and niche Biotech focussed in Oncology and will offer very exciting long-term prospects. This is quite a unique opportunity to join the company at early stages so there will be a lot of exposure. They work in exciting and innovative therapy areas.

    The role spans across pre-clinical through to clinical trials specifically in Oncology. They need a very experienced individual who is also happy to do hands on work. This is a very cross-functional role with oversight of an asset/compound.

    This is a permanent and full-time position. It is office-based in London offering an excellent salary + bonus + benefits (over £100K package).

    Skills Alliance are the exclusive partner for this role, please contact Mark Anderson for more details +44 207 220 6209 or click APPLY NOW!