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Regulatory Affairs CMC Director
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- This role provides CMC Regulatory expertise and leadership for commercial and development projects.
- Manages a CMC team who manage relevant submissions to US investigational new drug applications (IND), ex-US clinical trial applications, and new drug applications (NDAs).
- This role works closely with the Chemistry, Manufacturing and Controls (CMC), Regulatory Affairs, and Quality Assurance departments, as well as with cross-functional project teams.
- Liaise internally with other members of the Regulatory Affairs department to coordinate CMC changes with other aspects of the development programs.
- Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year.
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