Deborah M. Autor is Senior Vice President, Strategic Global Quality and Regulatory Policy at Mylan, the world’s third largest generics and specialty pharmaceutical company. In that role, Ms. Autor works to advance Mylan’s industry-leading efforts to establish high drug quality standards globally and to expand the world’s access to high quality medicine. She also oversees Mylan’s quality system and serialization implementation.
Prior to joining Mylan in 2013, Ms. Autor served for 11 years at FDA, most recently as Deputy Commissioner for Global Regulatory Operations and Policy. In that role, Ms. Autor supervised over 4,000 employees in FDA’s Office of Regulatory Affairs (ORA) and the Office of International Programs (OIP), in their efforts to confront the challenges of globalization and import safety. Prior to assuming the role of Deputy Commissioner, Ms. Autor served for five years as Director of the Office of Compliance of FDA’s Center for Drug Evaluation and Research (CDER). In that role, she led policy-making and enforcement for key public health programs for drugs including: current good manufacturing practices; human subject protection and bioresearch monitoring; marketed unapproved drugs; pharmaceutical import and export; Internet and health fraud; over-the-counter monograph compliance; adverse event reporting; registration and listing; risk evaluation and mitigation strategies; and drug recalls.
Before joining FDA, Ms. Autor was a trial attorney for seven years in the Office of Consumer Litigation of the U.S. Department of Justice, where she litigated civil and criminal cases on behalf of FDA and other federal law enforcement agencies. She began her legal career practicing food and drug law at the firms of Weil, Gotshal & Manges and Buc Levitt & Beardsley.
Ms. Autor’s contributions to public health have been recognized many times. She was awarded the 2011 Meritorious Executive Presidential Rank Award and the 2011 Food and Drug Law Institute’s Distinguished Service and Leadership Award; she also was a 2010 finalist for the prestigious Service to America Medal. In addition, the U.S. Department of Health and Human Services, FDA, CDER and DOJ decorated her with a total of more than 50 awards. At Mylan, Ms. Autor is continuing her work to improve drug quality and global access to safe, effective, high quality drugs.
Events Deborah Autor will be attending:
Impact of “The CDER Challenge” to Industry