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Maryll W. Toufanian is Senior Vice President — Regulatory Strategy and Policy at Amneal Pharmaceuticals Inc., where she leads the company’s efforts to develop top-level regulatory strategies supporting the launch and commercialization of key products across the specialty, biosimilar, and generic portfolios. She also leads Amneal’s government relations and public policy interface with state and federal policymakers in the legislative and executive branches.
Maryll joined Amneal from FDA’s Center for Drug Evaluation & Research (CDER), where she most recently served as Director of the Office of Generic Drug Policy, overseeing all regulatory and policy matters in the Office of Generic Drugs’ generic drug program. She previously served FDA in various senior leadership roles in CDER and the Office of the Commissioner, and as Associate Chief Counsel for Drugs in FDA’s Office of Chief Counsel. Prior to joining FDA, Maryll served as an associate with Zuckerman Spaeder LLP, specializing in food and drug and criminal defense matters. She began her legal career at Willkie Farr & Gallagher LLP, and clerked for the United States District Court for the District of Columbia.
Maryll holds a J.D. from New York University School of Law, an M.A. in English Literature from the University of Texas at Austin, and a B.A. from the University of Michigan in Afro-American and African Studies and English.