Susan Stewart, JD, LL.M

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Susan Stewart, JD has 30 years of experience in biopharmaceutical regulatory affairs and quality assurance, overseeing and developing innovative regulatory strategies and leading interactions with global health authorities. In addition to being an independent regulatory consultant for several years, she serves as chief regulatory officer for Frequency Therapeutics and Candel Therapeutics where she also oversees regulatory and quality functions, and previously was CRO at Kaleido Biosciences where she also senior vice president of regulatory and quality.  Prior to that, she served as 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) in regulatory and compliance roles, including serving as vice president, regulatory affairs, after beginning her career with Abbott Laboratories in regulatory and quality positions.  

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.  Sue is a Fellow of the Regulatory Affairs Professionals Society and holds both US and EU RAC certifications.