Regulatory CMC Strategy Manager

4 days ago

London, Greater London, United Kingdom Pfizer Full time
Job Description

Pfizer 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 objectives and align expectations.
  • Manage planning and monitoring activities to mitigate risks and contribute to global regulatory strategies.
  • Develop and implement regulatory strategies for projects across all aspects of drug development or manufacturing lifecycle.
  • Provide guidance and lead/co-lead projects, manage own time to meet objectives, and plan resource requirements.
  • Develop CMC documentation, coordinate and manage global submissions, and maintain product compliance.
  • Contribute to Global Chemistry Manufacturing and Controls projects, initiatives & actions, and prioritize assigned workload.
  • Investigate opportunities for regulatory innovation and promote the use of novel approaches within project teams.
  • Develop effective relationships with internal partners and leverage technical and regulatory knowledge to develop regulatory strategies and mitigate risks.
  • Execute regulatory policies and operational processes and deliver high-quality regulatory submissions.
Requirements:
  • Bachelor's Degree
  • Min 5+ years of experience in pharmaceutical or medical device industry
  • Min 3+ years of relevant pharmaceutical/medical device/IVD or combination product development and/or manufacturing experience
  • Skills and relevant experience that demonstrate CMC regulatory and quality expertise
  • Demonstrated commitment to scientific and regulatory integrity, quality compliance
  • Adaptable and self-motivated, able to prioritize effectively with strong problem-solving and planning abilities
  • Excellent planning, organizational, and project management skills
  • Advanced skills in written and verbal communications
  • Competent working knowledge of computer-based systems, such as Microsoft Office, controlled documentation systems
Preferred Qualifications:
  • Hands-on CMC authoring experience (investigational, initial registrations or post-approval)
  • Relevant medical device/IVD/combination product experience
  • Understanding of the regulatory requirements and development expectations for medical device and combination products
  • Understanding of medical device design and development expectations and design control requirements
What We Offer:
  • Annual base salary range: $99,900.00 to $166,000.00
  • Participation in Pfizer's Global Performance Plan with a bonus target of 15.0% of the base salary
  • Eligibility to participate in our share-based long-term incentive program
  • Comprehensive and generous benefits and programs to help our colleagues lead healthy lives and support each of life's moments

  • Regulatory CMC Manager

    1 day 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 day 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...

  • Senior Regulatory CMC Consultant

    6 days ago

    London, Greater London, United Kingdom Cpl Healthcare Full time

    Job SummaryCPL Life Sciences is collaborating with a global pharmaceutical company focused on the discovery, development, and commercialization of innovative medicines.As a Senior Regulatory CMC Consultant, you will be responsible for the development of CMC Strategy for a range of projects in the development phase, including the preparation of CMC...

  • Senior Regulatory CMC Consultant

    1 week ago

    London, Greater London, United Kingdom Cpl Healthcare Full time

    Job SummaryCPL Life Sciences is collaborating with a global pharmaceutical company focused on the discovery, development, and commercialization of innovative medicines.As a Senior Regulatory CMC Consultant, you will be responsible for the development of CMC Strategy for a range of projects in the development phase, including the preparation of CMC...

  • CMC Lead, Regulatory Affiars

    2 months ago

    London, Greater London, United Kingdom Hobson Prior Full time

    Hobson Prior is seeking a CMC Lead for Regulatory Affairs. This role will focus on leading a team in the field of gene therapy, reporting to the Vice President of Regulatory Affairs. The successful candidate will be responsible for developing and implementing regulatory strategies across all gene therapy projects, identifying and managing regulatory risks,...

  • CMC Regulatory Affairs Leader

    1 week 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...

  • Senior Manager, Global Regulatory Affairs

    3 days 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

    3 days 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...

  • Head of Global CMC Compliance

    4 days 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

    3 days 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

    8 hours 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,...

  • Head of Global CMC Compliance

    6 hours 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,...

  • Global CMC Compliance Leader

    4 days ago

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

    Job DescriptionJob Title: Global CMC Compliance LeaderJob Summary:Fraser Dove International is seeking a highly skilled and experienced Global CMC Compliance Leader to join our client, a leading pharmaceutical organization. As a key member of the global quality team, you will be responsible for ensuring regulatory compliance of all medicinal products and...

  • Global CMC Compliance Leader

    2 days ago

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

    Job DescriptionJob Title: Global CMC Compliance LeaderCompany: Fraser Dove InternationalJob Type: Full-timeLocation: RemoteJob Category: ComplianceAbout Us: Fraser Dove International is a leading executive search firm specializing in the life sciences industry. We help exceptional organizations source top talent to drive innovation and growth.About the...

  • Global CMC Compliance Leader

    3 days ago

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

    Job DescriptionJob Title: Global CMC Compliance LeaderJob Summary:Fraser Dove International is seeking a highly skilled and experienced Global CMC Compliance Leader to join our client, a leading pharmaceutical organization. As a key member of the global quality team, you will be responsible for ensuring regulatory compliance of all medicinal products and...

  • Global CMC Compliance Leader

    2 days ago

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

    Job DescriptionJob Title: Global CMC Compliance LeaderCompany: Fraser Dove InternationalJob Type: Full-timeLocation: RemoteJob Category: ComplianceAbout Us: Fraser Dove International is a leading executive search firm specializing in the life sciences industry. We help exceptional organizations source top talent to drive innovation and growth.About the...

  • Regulatory Strategy Senior Manager

    2 days ago

    London, Greater London, United Kingdom Lifelancer Full time

    Job DescriptionThe Regulatory Strategy Senior Manager will be responsible for contributing regional or global regulatory strategy expertise for development programs or marketed products. The Regulatory Strategy Senior Manager will serve as a regional regulatory lead or in some cases may also be a global regulatory lead for development and/or commercial...

  • Regulatory Strategy Senior Manager

    2 days ago

    London, Greater London, United Kingdom Lifelancer Full time

    Job DescriptionThe Regulatory Strategy Senior Manager will be responsible for contributing regional or global regulatory strategy expertise for development programs or marketed products. The Regulatory Strategy Senior Manager will serve as a regional regulatory lead or in some cases may also be a global regulatory lead for development and/or commercial...

  • Regulatory Strategy Senior Manager

    7 days ago

    London, Greater London, United Kingdom Lifelancer Full time

    Job DescriptionRegulatory Strategy Senior ManagerThe Regulatory Strategy Senior Manager will be responsible for contributing regional or global regulatory strategy expertise for development programs or marketed products. The Regulatory Strategy Senior Manager will serve as a regional regulatory lead, or in some cases may also be a global regulatory lead, for...

  • Regulatory Strategy Senior Manager

    6 days ago

    London, Greater London, United Kingdom Lifelancer Full time

    Job DescriptionRegulatory Strategy Senior ManagerThe Regulatory Strategy Senior Manager will be responsible for contributing regional or global regulatory strategy expertise for development programs or marketed products. The Regulatory Strategy Senior Manager will serve as a regional regulatory lead, or in some cases may also be a global regulatory lead, for...