Regulatory Chemistry Manufacturing Controls Manager

2 days ago

London, Greater London, United Kingdom Vertex Pharmaceuticals Full time
Job Title: Head of Manufacturing

Job Summary:
Vertex Pharmaceuticals is seeking a highly skilled Regulatory Chemistry Manufacturing Controls (CMC) Manager to lead the development and execution of global regulatory CMC strategies for investigational and marketed products. This role will contribute to the preparation and submission of regulatory CMC documentation and interact with Health Authorities for CMC topics. The successful candidate will provide regulatory support and guidance to cross-functional teams to ensure all applicable global regulatory requirements are considered and appropriately incorporated into investigational and commercial programs.

Key Responsibilities:
  1. Review and analyze CMC sections of regulatory submissions and interactions with regulatory agencies.
  2. Contribute to the development of global regulatory CMC strategies for investigational and/or commercial products.
  3. Collaborate with regulatory colleagues to develop global regulatory CMC strategies and submissions.
  4. Provide regulatory CMC guidance to cross-functional teams and key stakeholders.
  5. Influence regulatory assessment and guidance on product compliance topics, including change controls, deviations, and GMP investigations.
  6. Participate effectively on cross-functional teams and serve as the primary regulatory CMC contact for assigned products and projects.
Requirements:
  1. Strong interpersonal skills to exchange complex information with others and guide others.
  2. Proficiency in regulatory guidelines, including FDA, EMA, Health Canada, and ICH.
  3. Experience in preparing CMC submissions, including writing.
  4. Strategic thinking and strong problem-solving skills.
  5. Ability to collaborate and communicate effectively in an open, clear, complete, timely, and consistent manner.
  6. Strong sense of planning and prioritization, with the ability to work with all levels of management.
  7. Capable of strategic thinking with the ability to resolve complex and ambiguous situations.
  8. Sound knowledge of cGMP, FDA, EMA, and ICH.
Education:
  1. Bachelor's degree in Biology, Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics, or Medical Devices, or another related life-science field.

  • Regulatory Chemistry Manufacturing Controls Manager

    6 hours ago

    London, Greater London, United Kingdom Vertex Pharmaceuticals Full time

    Job Title: Head of ManufacturingJob Summary:Vertex Pharmaceuticals is seeking a highly skilled Regulatory Chemistry Manufacturing Controls (CMC) Manager to lead the development and execution of global CMC strategies for investigational and marketed products. This role will contribute to the preparation and submission of regulatory CMC documentation and...

  • Regulatory Chemistry Manufacturing Controls Manager

    4 hours ago

    London, Greater London, United Kingdom Vertex Pharmaceuticals Full time

    Job Title: Head of ManufacturingJob Summary:Vertex Pharmaceuticals is seeking a highly skilled Regulatory Chemistry Manufacturing Controls (CMC) Manager to lead the development and execution of global CMC strategies for investigational and marketed products. This role will contribute to the preparation and submission of regulatory CMC documentation and...

  • Regulatory Affairs Specialist

    2 weeks ago

    London, Greater London, United Kingdom VRS Regulatory Full time

    Job DescriptionA rare opportunity for an aspiring regulatory affairs professional to join the regulatory team at a global chemical products business:Work under the supervision of an experienced regulatory managerProvide regulatory support to a wide range of chemical productsOngoing and comprehensive trainingAn excellent opportunity to start and establish...

  • Regulatory Affairs Specialist

    2 weeks ago

    London, Greater London, United Kingdom VRS Regulatory Full time

    Job DescriptionA rare opportunity for an aspiring regulatory affairs professional to join the regulatory team at a global chemical products business:Work under the supervision of an experienced regulatory managerProvide regulatory support to a wide range of chemical productsOngoing and comprehensive trainingAn excellent opportunity to start and establish...

  • Regulatory Affairs Specialist

    7 days ago

    London, Greater London, United Kingdom VRS Regulatory Full time

    Regulatory Affairs OpportunityA unique chance to launch your career in chemical regulatory affairs with VRS Regulatory, a specialist scientific recruiter.About the Role:Work under the guidance of an experienced regulatory manager to provide support for a diverse range of chemical products.Conduct a variety of activities, including SDS authoring, updates,...

  • Regulatory Affairs Specialist

    6 days ago

    London, Greater London, United Kingdom VRS Regulatory Full time

    Regulatory Affairs OpportunityA unique chance to launch your career in chemical regulatory affairs with VRS Regulatory, a specialist scientific recruiter.About the Role:Work under the guidance of an experienced regulatory manager to provide support for a diverse range of chemical products.Conduct a variety of activities, including SDS authoring, updates,...

  • Regulatory Compliance Specialist

    6 days ago

    London, Greater London, United Kingdom The Medicines and Healthcare products Regulatory Agency Full time

    Good Manufacturing Practice InspectorAbout the RoleThe Medicines and Healthcare products Regulatory Agency is seeking a highly skilled Good Manufacturing Practice Inspector to join our Standards & Compliance Function within the Healthcare Quality and Access group.Key ResponsibilitiesConduct inspections at manufacturers, importers, wholesale dealers, and...

  • Regulatory Compliance Specialist

    6 days ago

    London, Greater London, United Kingdom The Medicines and Healthcare products Regulatory Agency Full time

    Good Manufacturing Practice InspectorAbout the RoleThe Medicines and Healthcare products Regulatory Agency is seeking a highly skilled Good Manufacturing Practice Inspector to join our Standards & Compliance Function within the Healthcare Quality and Access group.Key ResponsibilitiesConduct inspections at manufacturers, importers, wholesale dealers, and...

  • Regulatory Affairs Director

    6 days ago

    London, Greater London, United Kingdom wax. Full time

    Unlock Your Potential in CMC Regulatory AffairsWe're seeking a seasoned expert in Chemistry, Manufacturing, and Controls (CMC) to lead multi-modality projects from development to commercialisation.Key Responsibilities:Prepare and submit high-quality CMC packages for small and large molecules.Collaborate with Tech Ops, Global Regulatory Affairs, and Quality...

  • Regulatory Affairs Director

    6 days ago

    London, Greater London, United Kingdom wax. Full time

    Unlock Your Potential in CMC Regulatory AffairsWe're seeking a seasoned expert in Chemistry, Manufacturing, and Controls (CMC) to lead multi-modality projects from development to commercialisation.Key Responsibilities:Prepare and submit high-quality CMC packages for small and large molecules.Collaborate with Tech Ops, Global Regulatory Affairs, and Quality...

  • Regulatory Affairs Director

    6 days ago

    London, Greater London, United Kingdom wax. Full time

    Unlock Your Potential in Rare Disease TreatmentsWe're seeking a seasoned expert in Chemistry, Manufacturing, and Controls (CMC) to lead our regulatory affairs team. As a dynamic leader, you'll drive high-quality submissions and collaborate with cross-functional teams to ensure timely deliverables.Key Responsibilities:Prepare and submit CMC packages for small...

  • Regulatory Affairs Director

    5 days ago

    London, Greater London, United Kingdom wax. Full time

    Unlock Your Potential in Rare Disease TreatmentsWe're seeking a seasoned expert in Chemistry, Manufacturing, and Controls (CMC) to lead our regulatory affairs team. As a dynamic leader, you'll drive high-quality submissions and collaborate with cross-functional teams to ensure timely deliverables.Key Responsibilities:Prepare and submit CMC packages for small...

  • Regulatory Compliance Specialist

    7 days ago

    London, Greater London, United Kingdom The Medicines and Healthcare products Regulatory Agency Full time

    Good Manufacturing Practice InspectorAbout the RoleThe Medicines and Healthcare products Regulatory Agency is seeking a highly skilled Good Manufacturing Practice Inspector to join our Standards & Compliance Function within the Healthcare Quality and Access group.Key ResponsibilitiesConduct inspections at manufacturers, importers, wholesale dealers, and...

  • Regulatory Compliance Specialist

    7 days ago

    London, Greater London, United Kingdom The Medicines and Healthcare products Regulatory Agency Full time

    Good Manufacturing Practice InspectorAbout the RoleThe Medicines and Healthcare products Regulatory Agency is seeking a highly skilled Good Manufacturing Practice Inspector to join our Standards & Compliance Function within the Healthcare Quality and Access group.Key ResponsibilitiesConduct inspections at manufacturers, importers, wholesale dealers, and...

  • Regulatory CMC Strategy Manager

    2 weeks ago

    London, Greater London, United Kingdom Pfizer Full time

    Job DescriptionPfizer is seeking a highly skilled Regulatory CMC Strategy Manager to join our team. As a key member of our global regulatory affairs team, you will play a critical role in ensuring the successful development and approval of our pharmaceutical products.Key Responsibilities:Collaborate with cross-functional teams to progress Pfizer's business...

  • Regulatory CMC Strategy Manager

    2 weeks ago

    London, Greater London, United Kingdom Pfizer Full time

    Job DescriptionPfizer is seeking a highly skilled Regulatory CMC Strategy Manager to join our team. As a key member of our global regulatory affairs team, you will play a critical role in ensuring the successful development and approval of our pharmaceutical products.Key Responsibilities:Collaborate with cross-functional teams to progress Pfizer's business...

  • Regulatory Affairs Manager

    17 hours ago

    London, Greater London, United Kingdom Turner Regulatory Full time

    Principal Regulatory Officer / EU; Pharma & Generic Products / Project ManagerHybrid Working - 1-2 days in the Office per week required. Supervision and mentoring of a small team.Key Responsibilities:Liaise closely with Business Development, Regulatory Science, Pharmacovigilance, Product Launch, Artwork, Supply Chain and Quality colleagues.Prepare Regulatory...

  • Regulatory Affairs Manager

    18 hours ago

    London, Greater London, United Kingdom Turner Regulatory Full time

    Principal Regulatory Officer / EU; Pharma & Generic Products / Project ManagerHybrid Working - 1-2 days in the Office per week required. Supervision and mentoring of a small team.Key Responsibilities:Liaise closely with Business Development, Regulatory Science, Pharmacovigilance, Product Launch, Artwork, Supply Chain and Quality colleagues.Prepare Regulatory...

  • Regulatory CMC Manager

    2 weeks 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

    2 weeks 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...