Regulatory CMC Lead

2 weeks ago

London, Greater London, United Kingdom Vertex Full time

Job Title: Regulatory CMC Lead

Job Summary:

Vertex is seeking a highly skilled Regulatory CMC Lead to influence the execution of multi-product global regulatory CMC strategies for investigational and marketed products. This role contributes to the preparation and submission of regulatory CMC documentation and interactions with Health Authorities for CMC topics. The successful candidate will provide regulatory support and guidance to various cross-functional teams to ensure all applicable global regulatory requirements are considered and appropriately incorporated into investigational and commercial programs.

Key Responsibilities:

  • Reviews CMC sections of regulatory submissions, as well as interactions and responses with regulatory agencies.
  • Contributes to the development of global regulatory CMC strategies for investigational and/or commercial products.
  • Works with regulatory colleagues in the development of global regulatory CMC strategies and submissions.
  • Provides regulatory CMC guidance to cross-functional teams and key stakeholders.
  • Influences regulatory assessment and guidance on product compliance topics, including change controls, deviations, and GMP investigations.
  • Participates effectively on cross-functional teams and may serve as the primary regulatory CMC contact for assigned products and projects.

Requirements:

  • Strong interpersonal skills to exchange complex information with others and to guide others.
  • Proficiency in regulatory (FDA, EMA, Health Canada, and ICH) guidelines.
  • Experience in the preparation, including writing, of CMC submissions.
  • Strategic thinking and strong problem-solving skills.
  • Ability to collaborate and communicate in an open, clear, complete, timely, and consistent manner.
  • Strong sense of planning and prioritization, and the ability to work with all levels of management.
  • Capable of strategic thinking with the ability to resolve complex and ambiguous situations.
  • Sound knowledge of cGMP, FDA, EMA, ICH.

Education:

  • Bachelor's degree in Biology, Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics, or Medical Devices, or another related life-science field.

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