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Senior Scientist / Associate Director RACMC
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- Supports CMC regulatory compliance activities for portfolio biologics to meet US, International Conference on Harmonization (ICH), and other applicable regulations.
- This includes preparation, review, and approval of CMC documentation for BLA Supplements (PAS, CBE-0, CBE-30), Annual reports, Lot Distribution Reports, Biological Product Deviation Reports, and Drug Listings.
- Ensures that CMC documentation is complete, well organized, scientifically sound, of a high quality, aligned with the current regulations, and presented in a manner that facilitates Health Authority reviews.
- Evaluates CMC changes for portfolio biologics and determines filing strategies, provides expertise as regulatory CMC representative to project teams, and supports change implementation.
- Coordinates with regional/global RACMC, Quality Assurance, Pharmaceutical Technology, and other functional areas to secure approval of CMC changes and assess regulatory implications.
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