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Stephanie S. Kelly, JD, MS

GRA, Global Head of Regulatory Intelligence and Policy
Kyowa Kirin, United States

Ms. Stephanie Sabatino Kelly, J.D., M.S., Global Head of Regulatory Intelligence and Policy at Kyowa Kirin has over twenty years’ experience across the medical device, pharmaceutical and biotechnology industries. She started her career as a Medicinal Chemist at GlaxoSmithKline, while pursuing her Master’s Degree in Chemistry from Lehigh University and then her Law Degree from Widener University School of Law – Delaware. Ms. Kelly worked briefly as a Scientific Advisor in a well-reputed Intellectual Property Law Firm in the Philadelphia suburbs before transitioning into Regulatory Affairs.

Ms. Kelly worked as a consultant for Pfizer before moving to Siemens Healthineers and finding her passion in Regulatory and Standards Intelligence and Policy. Ms. Kelly also worked at CSL Behring as the NA Lead for Regulatory Intelligence and Policy before moving to Kyowa Kirin in 2021.

Ms. Kelly has represented organizations in numerous industry association working groups including PhRMA, AdvaMed, BIO and MITA, among others, spoken at several U.S. and International conferences, and has served on the Board of Directors for MITA and DITTA.

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