Program Coordinator, Sr. Lecturer
At Johns Hopkins, Jonathan S. Helfgott is a Program Coordinator and senior lecturer for the MS in Regulatory Science program.
Outside of Johns Hopkins, Helfgott is the executive director of global regulatory/clinical affairs and market access at Stage 2 Innovations. Prior to joining Stage 2 Innovations, Helfgott was the associate director for risk science within the Office of Scientific Investigations at FDA’s Center for Drug Evaluation & Research. Earlier, Helfgott was at the FDA’s Center for Devices and Radiological Health within the Division of Bioresearch Monitoring, where he specialized in computerized systems used in FDA regulated clinical investigations, teaching Clinical Development of Drugs & Biologics, International Regulatory Affairs, Validation in Biotechnology, and Biomedical Software Regulations.
Helfgott is the co-editor of the Food and Drug Law Institute’s 2009 Publication, “Biomedical Software Regulation.” He also has been published in peer-reviewed journals such as Applied Clinical Trials, RAPS Focus, Association of Clinical Research Professionals, FDLI Update, Touch Briefings, and Medical Device and Diagnostic Industry. Helfgott also continues to lecture and be involved with various regulatory professional organizations such as DIA, ACRP, RAPS, SoCRA, SCDM, AdvaMed, CHI, CBI, and FDANews.
Helfgott received a Bachelor of Science in cell biology and molecular genetics from the University of Maryland College Park and a Master of Science in bioscience regulatory affairs from Johns Hopkins University.