Deborah Autor

CEO
Autor Strategies, LLC
 

Deborah M. Autor uses her decades of wide-ranging, deep pharmaceutical-related experience to guide a range of organizations on highly sensitive strategic issues. She currently works as CEO of Autor Strategies, LLC; a Non-Executive Director of Pardes Biosciences, Inc. (NASDAQ: PRDS), an early-stage biopharmaceutical company that is developing a potential direct-acting, oral unboosted antiviral drug to treat and prevent SARS-CoV-2 infections; a Non-Executive Director of Amneal Pharmaceuticals, Inc. (NYSE: AMRX), a leading specialty and generic pharmaceutical company; and Chair of the Board of the FDA Alumni Association. Ms. Autor has also served as a Scientific Advisory Council Member of the Centre for Innovation in Regulatory Science and as a Board Member of the Antimicrobial Resistance Industry Alliance, the United States Pharmacopoeia Quality Institute, and the Parenteral Drug Association.

From 2019-2021, Ms. Autor was Global Head of Regulatory Excellence at AstraZeneca, where she led regulatory operations, international regulatory strategy, CMC, labeling, regulatory business development, processes, compliance, learning & development, policy, and intelligence across all therapy areas. Before joining AstaZeneca,

Ms. Autor was Head of Strategic Global Quality and Regulatory Policy and Head of Global Quality at Mylan N.V. Ms. Autor served for 12 years at FDA, most recently as Deputy Commissioner for Global Regulatory Operations and Policy. Before that, Ms. Autor was the Director of the Office of Compliance of the Center for Drug Evaluation and Research. Prior to joining FDA, Ms. Autor was a Trial Attorney in the Office of Consumer Litigation of the U.S. Department of Justice, where she litigated civil and criminal cases on behalf of FDA.

Ms. Autor has been decorated with over 50 awards, including the Meritorious Executive Presidential Rank Award and the Food and Drug Law Institute's Distinguished Service and Leadership Award. She also was a finalist for the Service to America Medal.

 

Sessions: 

Panel – Don’t Get Ready, Be Ready: Inspection Readiness Is a State of Mind