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Global Regulatory CMC Manager
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Full-time
- Participate in the development of the CMC regulatory strategy for small molecules, biologics and cell therapy submissions.
- These submissions include health authority briefing packages, IND/CTA, BLA/NDA and MAA regulatory filings.
- Prepare and review CMC submission documents, registration dossiers, health authority briefing packages and responses to health authorities through collaborations with relevant line functions and with minimal supervision.
- Responsible for the global regulatory evaluation of CMC change controls with supervision.
- 5-7 years in the pharmaceutical industry, preferably with 1-3 years CMC regulatory experience.
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