Jan Hewett joined Advarra as the Senior Vice President, FDA Regulatory Advisor in May 2025. Prior to joining Advarra, Jan served as Regulatory Counsel (Policy) at the U.S. Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) – Office of Compliance (OC) – Office of Scientific Investigations (OSI) for ten years. Jan has also served as the Director of the Yale University Human Research Protection Program for three years and the Assistant Director and Director, University of Michigan Institutional Review Board (IRBMED) from 2004 – 2012. She has also served as a Senior Grants and Contracts Officer in Research and Technology Development Services (RTDS) at Georgetown University, and as Supervisor of Research Operations at the Lombardi Cancer Center at Georgetown. In addition, while at Georgetown, Jan was also a Phase I Clinical Research Nurse Specialist in Oncology, and Clinical Research Nurse Coordinator in the General Clinical Research Center (GCRC) in the Department of Pharmacology – Division of Clinical Pharmacology.
Jan has served as a consumer representative member of the U.S. Food and Drug Administration’s Nonprescription Drugs Advisory Committee (NDAC) and has presented nationally and internationally on human research protection regulations.
Trained as a registered nurse in her native Australia, Jan received her B.S.N. from Georgetown University School of Nursing and her J.D. from the University of Michigan Law School.
She is co-author on a number of peer-reviewed articles in the areas of medicine, medical law, research results, Institutional Review Board, and Human Research Protection Program operations and regulatory requirements.