Business
Amneal Expands Leadership Team with Appointment of Senior Leaders in Quality and Regulatory
- Deepens leadership experience and capabilities to drive key growth areas of biosimilars, complex generics, injectables and specialty - Reem Malki joins as
About this update from Amneal Pharmaceuticals, Inc.
[{"type":"text","content":"\n- Deepens leadership experience and capabilities to drive key growth areas of biosimilars, complex generics, injectables and specialty\n- Reem Malki joins as Senior Vice President, Chief Quality Officer, and Maryll W. Toufanian joins as Senior Vice President, Regulatory Strategy and Policy\n\n BRIDGEWATER, N.J.--(BUSINESS WIRE)--\nAmneal Pharmaceuticals, Inc. (NYSE: AMRX) (“Amneal” or the “Company”) today announced it has appointed Reem Malki as Senior Vice President, Chief Quality Officer, and Maryll W. Toufanian as Senior Vice President, Regulatory Strategy and Policy.\n\nMs. Malki brings over 30 years of quality operations and regulatory experience in the pharmaceuticals industry. She joins the Company from Alvotech, where she served as Chief Quality Officer responsible for all quality functions advancing the company’s growing biosimilar pipeline. Prior to joining Alvotech, Ms. Malki held various senior leadership roles at Mylan, including Head of Global Quality Operations. While at Mylan, she also served as VP of EMEA Quality Operations. Prior to Mylan, Ms. Malki held positions of increasing responsibility in quality control at Andrx Pharmaceuticals leading up to its acquisition by Watson Pharmaceuticals, most recently as Director of Quality Control. She began her career in the pharmaceutical industry at Wyeth Ayerst Laboratories. Ms. Malki holds a Bachelor of Science in Chemistry from the University of Maine.\n\nMs. Toufanian joins Amneal from the FDA’s Center for Drug Evaluation & Research (CDER) where she recently served as Director of the Office of Generic Drug Policy overseeing all regulatory and policy matters of the Office of Generic Drugs’ (OGD) generic drug program, including the development and implementation of regulations, guidance, policy statements, and publication of FDA’s Orange Book. A nationally recognized expert in drug regulation, Ms. Toufanian previously served various other senior leadership roles with the FDA, including as Deputy Director for Clinical and Regulatory Affairs (Acting) for OGD; Deputy Director, Office of Generic Drug Policy; Director, Division of Legal and Regulatory Support for OGD; Principal Advisor to the Deputy Commissioner for the FDA’s Office of Policy, Legislation and International Affairs; and as Associate Chief Counsel for Drugs for the FDA’s Office of Chief Counsel. Prior to j...