Judy Lin, MS
Director, CMC
Bristol Myers Squibb


Judy Lin, is currently a Director in Global Regulatory Science – Chemistry Manufacturing and Controls (GRS-CMC) at Bristol Myers Squibb. She has over 20 years of pharmaceutical industry experience with roles in analytical development and regulatory sciences. In her current role, she led a group of regulatory scientists in developing and CMC regulatory strategies for initial marketing applications and post-approval change variations/supplements, by interfacing with technical experts in process/analytical development, quality assurance, and health authorities around the world.

Prior to becoming a regulatory science professional, Judy has extensive experience in pharmaceutical development with a focus on analytical control strategy. She led analytical development groups in developing/validating/transferring/lifecycle maintenance of analytical methods, as well as the overall analytical control strategy for API and drug product manufacturing processes.

Judy is also active in external organizations, serving as a member of the USP expert committee, regulatory advisory committee of IQ Consortium, and Eastern Analytical Symposium Governance Board.

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