- Email: [email protected]
Jeremiah J. Kelly is the Chief of FDA Regulatory Law, Office of the Staff Judge Advocate (JAG), U.S. Army Medical Research and Materiel Command (USAMRMC) located at Fort Detrick, Maryland.
Mr. Kelly’s advises the Commanding General, USAMRMC, on regulatory and acquisition strategy for the development and life-cycle of drugs, biologics and medical devices to treat the unique medical needs of the U.S. Army. He also advises the Department of Defense (DoD) Joint Program Executive Office (JPEO) for Chemical and Biological Defense/Joint Project Management Office (JPM) for Medical Countermeasure Systems (MCS) on the development, acquisition and life-cycle management of medical countermeasures to protect against a chemical, biological, radiological or nuclear attack.
Mr. Kelly’s legal practice includes the integration of food and drug law, R&D contracting, intellectual property, fiscal law, Federal assistance agreements (grants and cooperative agreements), technology transfer (licensing), and cooperative research & development agreements (CRADAs). From 2001 to 2008, he served in the Office of the Commissioner, U.S. Food and Drug Administration (FDA), spending time in both the Office of Legislation (OL) and Office of the Chief Counsel (OCC), where he specialized in analyzing legislation for its impact on FDA’s regulatory authority and advised the Commissioner of Food and Drugs on legislative strategy. From 2008 to 2011, Mr. Kelly was in private law practice at Whiteford, Taylor and Preston LLP in Washington D.C. and Baltimore, MD, where he was a litigator in Federal courts specializing in complex litigation and food and drug law.
Mr. Kelly is the author of a number of food and drug law publications and was a member of the Editorial Advisory Board of the Food and Drug Law Journal, published by the Food and Drug Law Institute (FDLI), for a number of years. He received his Juris Doctor from the University of Maryland School of Law, holds a Master’s Degree in Public Policy from the George Washington University’s School of Business and Public Management, and received his B.A. in Political Science from McDaniel College (formerly Western Maryland College). He received his Phase III Project Management Certification from the U.S. Naval Postgraduate School in 2014 and his Regulatory Affairs Certification (RAC) in 2014. Mr. Kelly is a guest lecturer in the Graduate Regulatory Affairs Program at Northeastern University. In addition, he is a part-time lecturer in the Biotechnology and Management Program at Mount St. Mary's University.