Chemistry Manufacturing Controls Manager - London, United Kingdom - Vertex

Description

Job Description

General Summary:

The Chemistry Manufacturing Controls Manager will influence the execution of multi-product global regulatory CMC strategies for marketed products. This role contributes to the preparation and submission of regulatory CMC documentation and with interactions with Health Authorities for CMC topics. This role also provides regulatory support and guidance to various cross functional teams to ensure all applicable global regulatory requirements are considered and appropriately incorporated into commercial programs.

Key Duties and Responsibilities:

• Reviews CMC sections of regulatory submissions, as well as the interactions and responses with regulatory agencies
• Contributes to the development of global regulatory CMC strategies for commercial products
• Works with regulatory colleagues in 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

Knowledge and Skills:

• 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 ability to resolve complex and ambiguous situationsSound knowledge of cGMP, FDA, EMA, ICH

Education and Experience:

• Bachelor's degree, with a preference in Biology, Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics or Medical Devices, or another related life-science field
• Extensive experience in the pharmaceutical industry or related field, or the
  equivalent combination of education and experience
• Requires a high level of experience in CMC regulatory post approval variations