With over 30 of experience at the highest levels of government and regulated industry, Deb Autor brings an unparalleled range of expertise across regulatory, quality, compliance, business strategy, policy, and law. This breadth and depth of experience, combined with HIC’s deep bench of cross-functional technical expertise, makes HIC a sought-after advisor in both the private and public sectors.

Deb’s government career spanned two decades, culminating as Deputy Commissioner of the Food and Drug Administration from 2011-2013. In that role, Deb oversaw all the agency’s inspections and international operations, directing 4,500 employees in the FDA’s Office of Regulatory Affairs and Office of International Programs. Prior to that, Deb was Director of the Office of Compliance in FDA’s Center for Drug Evaluation and Research, where she led enforcement and policy making for compliance with all drug requirements, including drug approval; current good manufacturing practices (GMP); human subject protection and bioresearch monitoring (GCP); import and export; and recalls. Before FDA, Deb was a Trial Attorney at the U.S. Department of Justice, where she was first chair for dozens of civil and criminal cases under the Federal Food, Drug, and Cosmetic Act and other consumer protection statutes.

In addition to this wealth of government experience, Deb has also been a hands-on leader of key functions in both the brand and generic pharmaceutical industries. From 2019-2021, Deb was Global Head of Regulatory Excellence for AstraZeneca, where she ran regulatory operations, international regulatory strategy, CMC, labeling, regulatory business development, processes, compliance, learning & development, policy, and intelligence across all therapy areas globally. In that role, she also shaped internal and external policy on groundbreaking issues such as digital health, real world evidence, novel clinical trial designs, and new regulatory partnerships.

Before joining AstraZeneca, Deb was Head of Strategic Global Quality and Regulatory Policy and Head of Global Quality at Mylan. Deb led Mylan’s largest function globally (5,000 people), overseeing the quality of 60 billion doses of medicine annually. Among other things, she devised and implemented a structure for quality system improvements across 50 manufacturing sites and dozens of regulatory systems. She also integrated three newly acquired businesses, creating synergies and assuring business continuity.

Beyond her current advisory work, Deb uses her decades of wide-ranging, deep pharmaceutical-related experience in the Board room to guide organizations on highly sensitive strategic issues. She currently works as a Non-Executive Director and member of the Audit and Conflicts Committees of Amneal Pharmaceuticals, Inc. (NASDAQ: AMRX), a leading specialty and generic pharmaceutical company. She also served as a Non-Executive Director and member of the Nominating and Governance Committee and Science and Technology Committee of Pardes Biosciences, Inc., a public clinical stage biopharmaceutical company that was developing a potential direct-acting, oral antiviral drug to treat and prevent SARS-CoV-2 infections.

Deb has been a highly visible expert for many years. Since 2018, she has served as Chair of the Board of the FDA Alumni Association, where she continues to maintain close connections with the agency while working to support its mission. Deb has testified in Congressional hearings and conducted international negotiations, diplomatic missions, and briefings for the White House, Congress, Office of the Secretary of Health and Human Services, the Centers for Disease Control and Prevention, and the U.S. Departments of Defense and State. She has appeared in national and international print and television media, including the New York Times, Wall Street Journal, USA Today, LA Times, Boston Globe, NBC, ABC, CBS, and CNN.

Deb has been decorated with over 50 governmental awards including the Presidential Rank Award. She was also a finalist for the Service to America Medal, known as the “Oscars of Government Service,” for high-impact contributions critical to the health, safety, and well-being of Americans. Deb has earned degrees or certificates from the Harvard Business School, Harvard Kennedy School of Government, Kellogg School of Management at Northwestern University, Boston University School of Law, and Columbia University.