Senior Director, Regulatory Affairs
Ascendis Pharma
Mary Wilhelm MSc, MSRA, DRSc, RAC (EU, US) has over thirty years of experience within the pharmaceutical and biotechnology industries. She is currently a Global Regulatory Lead at Ascendis Pharma and is responsible for the development of regulatory strategies for the company’s growth hormone program. In this role, Mary brings experience in developing regulatory intelligence and strategy, identifying regulatory risk mitigation and contingency plans, interacting with domestic and international regulatory agencies, and optimizing filing outcomes for both investigational and commercial drug products. Mary also has a strong background in quality assurance and quality control and has supported the manufacture of food additives, bulk excipients, and cosmetic ingredients.
Mary holds a Doctorate in Regulatory Science from the School of Pharmacy at the University of Southern California (USC). In her dissertation work, she studied “Regulatory Agreements for Drug Development Collaboration” which explored the views of industry professionals on the need for and current use of standalone regulatory agreements. Mary has also earned a Masters in Regulatory Science from San Diego State University, and three degrees from Purdue University: Chemistry (MS), Chemistry (BS), and Textile Science (BS). She also achieved Regulatory Affairs Certification from the Regulatory Affairs Professional Society (RAPS) for both the EU and US.
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Monday, September 12, 2022
1:30 PM – 2:00 PM MST