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Global Regulatory CMC Manager
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- Prerequisites: BS/BA degree in Scientific Discipline with 3 years in the pharmaceutical industry, preferably with 1 year CMC regulatory experience
- Participate in the development of the CMC regulatory strategy for biologics 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.
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