Niraj Mehta, Ph.D., is the Associate Director for Global Regulatory Policy in the Office of Global Regulatory Operations and Policy at the U.S. Food and Drug Administration. Dr. Mehta was a key member of team that negotiated the amended Pharmaceutical Annex to the 1998 US-EU Mutual Recognition Agreement in 2017. Dr. Mehta joined FDA in 2008, as a Senior Pharmacologist within the Center for Drug Evaluation’s Office of New Drugs and then the Office of Compliance. Dr. Mehta received his Ph.D. in Pharmacology and Molecular Sciences from the Johns Hopkins University School of Medicine in 2007.