Manager, Regulatory CMC

The Manager, Regulatory Chemistry Manufacturing Controls will 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 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 investigational and commercial programs.,

• 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 investigational and/or 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.
  Strong interpersonal skills to exchange complex information with others and to guide others.
• Proficiency in regulatory (SFDA, 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 situations.
• Sound knowledge of cGMP, FDA, EMA, ICH., Bachelor's degree in Biology, Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics or Medical Devices, or another related life-science field
• Experience in the pharmaceutical industry or related field, or the equivalent combination of education and experience.