Upvote
Downvote
Director, CMC Regulatory Affairs
Share Job
- Suggest Revision
Full-time
- The Director will lead key, strategic CMC regulatory activities for investigational and/or early commercial biopharmaceutical products.
- Will serve as a key strategic partner representing Global CMC Regulatory on Regulatory Networks and Matrix Teams, providing and overseeing strategic direction and guidance to Biopharmaceutical, Pharma Supply Chain, Clinical Trial Supply, Quality Assurance, and Commercial interfaces on both global project and key strategic business initiatives.
- May participate in corporate evaluation and provide CMC regulatory support/advice to in-licensing and divestment projects.
- Delivers CMC regulatory strategy to support major inspections (eg PAI's) or quality incidents (PIRCs).
- Ensures all appropriate strategic CMC regulatory aspects for clinical trials, product release and stability are in place, to avoid clinical holds, and to ensure continuity of market supply.
Expired 2 months agoInactive Job
Similar Job
Relevance
Active