Deborah M. Autor, JD
Mylan, Inc.
Head of Strategic Global Quality & Regulatory Policy
Deb Autor is Head of Strategic Global Quality and Regulatory Policy at Mylan, one of the largest generics and specialty pharmaceutical companies in the world. In this role, Deb represents Mylan’s diverse and complex operations to government officials globally and advises Mylan’s most senior leaders on how to navigate and influence the regulatory landscape. Previously, as Mylan’s Global Head of Quality, Deb managed thousands of personnel around the world, driving quality improvements across scores of manufacturing sites.
Prior to joining Mylan in 2013, Deb served for 12 years at FDA, most recently as Deputy Commissioner for Global Regulatory Operations and Policy, where she supervised more than 4,000 employees in FDA’s Office of Regulatory Affairs and Office of International Programs in their efforts to confront the challenges of globalization and import safety. She also served for five years as Director of the Office of Compliance of FDA’s Center for Drug Evaluation and Research, where she led policymaking and enforcement for key programs for drugs, including current good manufacturing practices, human subject protection, and marketed unapproved drugs. Before joining FDA, Deb served for six years as a Trial Attorney at the Office of Consumer Litigation of the U.S. Department of Justice, where she litigated civil and criminal cases on behalf of FDA.
Deb is a member of the ISPE Quality Metrics Core Team.
Prior to joining Mylan in 2013, Deb served for 12 years at FDA, most recently as Deputy Commissioner for Global Regulatory Operations and Policy, where she supervised more than 4,000 employees in FDA’s Office of Regulatory Affairs and Office of International Programs in their efforts to confront the challenges of globalization and import safety. She also served for five years as Director of the Office of Compliance of FDA’s Center for Drug Evaluation and Research, where she led policymaking and enforcement for key programs for drugs, including current good manufacturing practices, human subject protection, and marketed unapproved drugs. Before joining FDA, Deb served for six years as a Trial Attorney at the Office of Consumer Litigation of the U.S. Department of Justice, where she litigated civil and criminal cases on behalf of FDA.
Deb is a member of the ISPE Quality Metrics Core Team.