Jonathan Helfgott

At Johns Hopkins, Jonathan Helfgott is a program coordinator and senior lecturer for the MS in Regulatory Science program.

Helfgott is a healthcare executive specializing in U. S. Food and Drug Administration regulatory strategy, clinical development, and market access. In this role, he provides expertise to companies across all phases of medical product commercialization, overseeing global regulatory submissions, clinical trial design and execution, health authority communications, and market entry strategies. He is also the Founder of FDA Partners, a boutique advisory firm focused on global regulatory and clinical strategy.

Previously, Helfgott served at the FDA from 2006 to 2015, most recently as Associate Director for Risk Science in the Office of Scientific Investigations at the Center for Drug Evaluation & Research. He also held roles as a Compliance Officer and Pre-Market Reviewer at the Center for Devices & Radiological Health, where he specialized in Digital Health Technologies and Software as/in a Medical Device.

Helfgott is the elected President of the Association of Graduate Regulatory Educators and has lectured extensively at academic institutions and professional organizations. His work has been featured in The Washington Post article, Regulatory Science Degrees Help Researchers Think Outside the Lab. He is a co-editor of the Food and Drug Law Institute’s Biomedical Software Regulation, a contributing member of the Clinical Trials Transformation Initiative – Digital Health Technologies, and has published extensively in Applied Clinical Trials and Medical Device and Diagnostic Industry.

Earlier in his career, Helfgott was a research fellow at the National Institutes of Health, where he supported genomic research and clinical study design at the National Institute on Aging under the Intramural Research Training Award program.

He holds an MS in Bioscience Regulatory Affairs from Johns Hopkins University and a BS in Cell/Molecular Biology & Genetics from the University of Maryland.