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Director, Regulatory Affairs CMC
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- This position is responsible for providing CMC regulatory strategies and leading the preparation of CMC sections of regulatory submissions to support the clinical development and eventual marketing approval of company pipeline compounds and products.
- Provide CMC regulatory strategies to support the investigational products' clinical development and eventual marketing approval.
- Lead the preparation and maintenance of the CMC / quality sections for regulatory submission, including initial submission of IND, IMPD/CTA, NDA, MAA, and amendments to Health Authorities (HAs), and preparation of responses to queries from HAs.
- An advanced degree (M.S. or Ph. D.) in Pharmaceutical Science, Chemistry, Chemical Engineering, or a related field is desired.
- 10+ years of pharmaceutical/biotech drug development experience with 5+ years of experience in global CMC regulatory affairs with working experience and content knowledge in CMC development of NCEs / small molecules
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