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Repeat Solutions Circle
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Susan Stewart, JD, LLM, RAC, FRAPS

Chief Regulatory Officer
Rezolute Bio

Susan Stewart, J.D. LL.M RAC FRAPS, has more than 35 years of experience in biopharmaceutical regulatory affairs and quality assurance, overseeing and developing innovative regulatory strategies and leading interactions with global health authorities for drugs and biologics aimed at addressing unmet medical needs. In addition to being an independent regulatory consultant for several years, she serves as fractional Chief Regulatory Officer for Rezolute Bio and Candel Therapeutics. Previously Sue served as CRO at Frequency Therapeutics, CRO at Kaleido Biosciences, Senior Vice President of regulatory affairs, quality and compliance at Tokai Pharmaceuticals and Vice President, regulatory affairs at Transmolecular Therapeutics. She also spent 13 years at Genzyme Corporation (Sanofi) including serving as Vice President, regulatory affairs after beginning her career with Abbott Laboratories in regulatory and quality positions. She is the Regulatory Advisor for The Termeer Foundation, and as a guest lecturer at Stanford University, MIT and Harvard Medical School she shares her knowledge of regulatory processes and strategy.
Susan received her J.D. from Concord Law School at Purdue University Global, her LL.M from the Maurice A. Deane School of Law, Hofstra University, and her B.A. from the University of Massachusetts. She is a Fellow of the Regulatory Affairs Professionals Society, served terms as a director on the RAPS Board, and holds both US and EU RAC certifications.

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