DON SIMS Ph.D.

Don Sims
Director of Regulatory Affairs

Don is a senior CMC regulatory and quality/compliance manager providing strategic advice and guidance in the areas of quality, CMC regulatory compliance, operations management and technical writing. His experience spans small and large molecules, including DNA plasmid vaccines.   With expert knowledge of cGMP and CMC requirements, Don efficiently assembles IND/NDAs/BLAs, including eCTD format, and effectively resolves any submission/compliance issues with regulatory agencies.    Don has extensive experience managing day-to-day Quality Assurance operations within pharmaceutical production environments.   He devises and implements scalable and comprehensive quality systems that support the production and commercialization of clinical products.    His professional experience includes progressive positions at CIMA Labs, Solvay Pharmaceuticals, and Apollon.

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