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Director Regulatory CMC
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$187,100 - $280,700 a year
Full-time
- ResponsibilitiesIn collaboration with regulatory leads and cross-functional CMC Teams, lead generation of CMC related submissions and components, including clinical trial applications, marketing applications, regulatory agency briefing packages, and response to regulatory authority queries.
- Incorporate regulatory strategy and well positioned content into high quality submissions to support successful outcomes Design, develop, and implement submission shell documents and best practices for CTD quality modules to streamline preparation of CMC submission content Create and maintain CMC core dossier to support consistent global submissions Serve as an integral member of cross-functional CMC team(s) and provide regulatory CMC leadership.
- Direct interaction with global health authorities.
- Represent Spark Regulatory CMC at health authority meetings.
- Education and Experience Requirements BS in Biological Science required, MS in Biological Science preferred (e.g. Virology, Molecular Biology, Immunology, Cell Biology.
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