Upvote
Downvote
CMC Manager
Share Job
- Suggest Revision
- 3-5+ years in the pharmaceutical industry, preferably with 2+ years CMC regulatory experience
- Participate in the development of the CMC regulatory strategy for small molecules.
- These submissions include health authority briefing packages, IND/CTA, NDA and MAA regulatory filings.
- Responsible for the global regulatory evaluation of CMC change controls with supervision.
- Represent Regulatory CMC on cross-functional development/commercial teams and Regulatory Affairs teams.
Active Job
Updated 2 months agoSimilar Job
Relevance
Active