Current jobs related to Regulatory Affairs – Senior CMC Dossier Manager - London, Greater London - Cpl

  • CMC Regulatory Affairs Leader

    2 weeks ago

    London, Greater London, United Kingdom wax. Full time

    Unlock Your Potential in CMC Regulatory AffairsWe are seeking a seasoned expert in Chemistry, Manufacturing, and Controls (CMC) to lead our regulatory affairs team. As a dynamic leader, you will steer multi-modality projects from development to commercialisation, ensuring high-quality regulatory submissions.Key Responsibilities:Lead the preparation and...

  • CMC Regulatory Affairs Specialist

    7 hours ago

    London, Greater London, United Kingdom Parexel Full time

    Job Title: CMC Regulatory Affairs SpecialistParexel Consulting is seeking a skilled and experienced CMC Regulatory Affairs Specialist to join our team. In this role, you will have the opportunity to utilize your expertise in CMC, exceptional communication skills, and strong writing experience, contributing to our clients' success in the pharmaceutical...

  • CMC Regulatory Affairs Specialist

    5 hours ago

    London, Greater London, United Kingdom Parexel Full time

    Job Title: CMC Regulatory Affairs SpecialistParexel Consulting is seeking a skilled and experienced CMC Regulatory Affairs Specialist to join our team. In this role, you will have the opportunity to utilize your expertise in CMC, exceptional communication skills, and strong writing experience, contributing to our clients' success in the pharmaceutical...

  • Global CMC Compliance Leader

    7 days ago

    London, Greater London, United Kingdom Fraser Dove International Full time

    Global CMC Compliance Opportunity **Job Summary** Fraser Dove International is partnering with a leading pharmaceutical organization to find a strategic leader to oversee Global CMC Compliance. As the Head of CMC Compliance, you will be responsible for ensuring regulatory compliance of all medicinal products and medical devices with applicable guidelines,...

  • Global CMC Compliance Leader

    7 days ago

    London, Greater London, United Kingdom Fraser Dove International Full time

    Global CMC Compliance Opportunity **Job Summary** Fraser Dove International is partnering with a leading pharmaceutical organization to find a strategic leader to oversee Global CMC Compliance. As the Head of CMC Compliance, you will be responsible for ensuring regulatory compliance of all medicinal products and medical devices with applicable guidelines,...

  • Regulatory CMC Manager

    7 days ago

    London, Greater London, United Kingdom Vertex Full time

    Job Title: Regulatory CMC ManagerJob Summary:Vertex is seeking a highly skilled Regulatory CMC Manager to join our team. As a key member of our regulatory affairs team, you will be responsible for influencing the execution of multi-product global regulatory CMC strategies for investigational and marketed products.Key Responsibilities:Review and analyze CMC...

  • Regulatory CMC Manager

    7 days ago

    London, Greater London, United Kingdom Vertex Full time

    Job Title: Regulatory CMC ManagerJob Summary:Vertex is seeking a highly skilled Regulatory CMC Manager to join our team. As a key member of our regulatory affairs team, you will be responsible for influencing the execution of multi-product global regulatory CMC strategies for investigational and marketed products.Key Responsibilities:Review and analyze CMC...

  • Senior Manager, Global Regulatory Affairs

    2 weeks ago

    London, Greater London, United Kingdom GlaxoSmithKline Full time

    Job SummaryWe are seeking a highly experienced Senior Manager, Global Regulatory Affairs to join our team at GlaxoSmithKline. As a key member of our regulatory affairs team, you will be responsible for leading CMC regulatory activities in the late development and/or lifecycle management of our products.Key ResponsibilitiesDevelop and Implement CMC Regulatory...

  • Senior Manager, Global Regulatory Affairs

    2 weeks ago

    London, Greater London, United Kingdom GlaxoSmithKline Full time

    Job SummaryWe are seeking a highly experienced Senior Manager, Global Regulatory Affairs to join our team at GlaxoSmithKline. As a key member of our regulatory affairs team, you will be responsible for leading CMC regulatory activities in the late development and/or lifecycle management of our products.Key ResponsibilitiesDevelop and Implement CMC Regulatory...

  • Regulatory CMC Manager

    1 week ago

    London, Greater London, United Kingdom Vertex Full time

    Job Summary:Vertex is seeking a highly skilled Regulatory CMC Manager to join our team. As a key member of our regulatory affairs department, you will play a critical role in influencing the execution of multi-product global regulatory CMC strategies for investigational and marketed products.Key Responsibilities:Review and analyze CMC sections of regulatory...

  • Regulatory CMC Manager

    1 week ago

    London, Greater London, United Kingdom Vertex Full time

    Job Summary:Vertex is seeking a highly skilled Regulatory CMC Manager to join our team. As a key member of our regulatory affairs department, you will play a critical role in influencing the execution of multi-product global regulatory CMC strategies for investigational and marketed products.Key Responsibilities:Review and analyze CMC sections of regulatory...

  • Strategic Leader for Global CMC Compliance

    7 days ago

    London, Greater London, United Kingdom Fraser Dove International Full time

    Head of CMC Compliance OpportunityFraser Dove International is partnering with a leading pharmaceutical organization to find a strategic leader to oversee Global CMC Compliance.About the RoleThe Head of CMC Compliance will be responsible for ensuring regulatory compliance of all medicinal products and medical devices with applicable guidelines, regulations,...

  • Strategic Leader for Global CMC Compliance

    7 days ago

    London, Greater London, United Kingdom Fraser Dove International Full time

    Head of CMC Compliance OpportunityFraser Dove International is partnering with a leading pharmaceutical organization to find a strategic leader to oversee Global CMC Compliance.About the RoleThe Head of CMC Compliance will be responsible for ensuring regulatory compliance of all medicinal products and medical devices with applicable guidelines, regulations,...

  • Head of Global CMC Compliance

    7 days ago

    London, Greater London, United Kingdom Fraser Dove International Full time

    Job Title: Head of CMC ComplianceFraser Dove International is partnering with a leading pharmaceutical organization to find a strategic leader to oversee Global CMC Compliance.About the Role:The Head of CMC Compliance will be responsible for ensuring regulatory compliance of all medicinal products and medical devices with applicable guidelines, regulations,...

  • Head of Global CMC Compliance

    7 days ago

    London, Greater London, United Kingdom Fraser Dove International Full time

    Job Title: Head of CMC ComplianceFraser Dove International is partnering with a leading pharmaceutical organization to find a strategic leader to oversee Global CMC Compliance.About the Role:The Head of CMC Compliance will be responsible for ensuring regulatory compliance of all medicinal products and medical devices with applicable guidelines, regulations,...

  • Head of Global CMC Compliance

    2 weeks ago

    London, Greater London, United Kingdom Fraser Dove International Full time

    About the RoleWe are seeking a highly experienced and skilled professional to lead our Global CMC Compliance function. As the Head of Global CMC Compliance, you will be responsible for ensuring regulatory compliance of all medicinal products and medical devices with applicable guidelines, regulations, and approved authorizations.Key ResponsibilitiesDevelop...

  • Head of Global CMC Compliance

    2 weeks ago

    London, Greater London, United Kingdom Fraser Dove International Full time

    About the RoleWe are seeking a highly experienced and skilled professional to lead our Global CMC Compliance function. As the Head of Global CMC Compliance, you will be responsible for ensuring regulatory compliance of all medicinal products and medical devices with applicable guidelines, regulations, and approved authorizations.Key ResponsibilitiesDevelop...

  • Regulatory Affairs Scientist Placement

    2 weeks ago

    London, Greater London, United Kingdom Industry Placements Full time

    Job Overview:Job Title: Associate Regulatory Affairs ScientistThis role will be based in a Hybrid working arrangement.We offer exciting 12-month placement opportunities to students that are looking to work with us to deliver on our mission to save and improve lives. A placement with us will give you the opportunity to collaborate alongside subject matter...

  • Regulatory Affairs Scientist Placement

    2 weeks ago

    London, Greater London, United Kingdom Industry Placements Full time

    Job Overview:Job Title: Associate Regulatory Affairs ScientistThis role will be based in a Hybrid working arrangement.We offer exciting 12-month placement opportunities to students that are looking to work with us to deliver on our mission to save and improve lives. A placement with us will give you the opportunity to collaborate alongside subject matter...

  • Head of Global CMC Compliance

    1 week ago

    London, Greater London, United Kingdom Fraser Dove International Full time

    Job Title: Head of Global CMC ComplianceFraser Dove International is partnering with a leading pharmaceutical organization to find a strategic leader to oversee Global CMC Compliance.About the Role:The Head of Global CMC Compliance will be responsible for ensuring regulatory compliance of all medicinal products and medical devices with applicable guidelines,...

Regulatory Affairs – Senior CMC Dossier Manager

4 months ago

London, Greater London, United Kingdom Cpl Full time

Job Title: Regulatory Affairs – Senior CMC Dossier Manager

Job Type: Contract position until December 2024, inside IR35

Rate: Up to £85ph PAYE or Umbrella

Location: UK or Europe (Remote-based)

CPL has partnered with a world-leading Biotech looking for an experienced Regulatory CMC leader to work on a developing rare disease portfolio. This will be supporting two major projects and will be responsible for working as a Regulatory CMC Dossier Writer for complex developing biologics. The preferred candidate has prior experience with Microbial Vectors and has experience writing and authoring CMC sections from conception to submission.

Job Responsibilities include;

· Responsible, with limited guidance from the manager, for developing the technical eCTD sections to support Regulatory CMC dossier applications

· Authors/drives, as appropriate, sections of the CMC dossier and evaluates/ensures that final versions comply with regulatory requirements and fulfill regulatory agency expectations with limited guidance from the manager.

· Experience in writing Regulatory CMC sections from scratch including CTA, IND, IMPD, BLA, NDA, and MAAs.

· Supports the technical functions in the development of responses to health authority inquiries in support of major applications with limited guidance from the manager.

Candidate Requirements Include;

· Life Science degree or equivalent

· Minimum of 8 years' experience related to Regulatory CMC

· Must have experience with Microbial Vectors.

· Previous experience authoring CMC BLA's from scratch.

If this opportunity is of interest to you please forward your up-to-date CV to