Peter Manilla

Peter Manilla is a Regulatory Professional with extensive expertise in drug, biologic, and medical device product development, GxPs, and regulatory strategy.

With 25 years of experience at the U.S. Food and Drug Administration (FDA), Peter retired from the Federal Government and now offers freelance and temporary remote regulatory affairs services.

His educational background includes a Master of Science (MSc) in Biotechnology from The Johns Hopkins University, a Master of Public Administration (M.P.A.) from Penn State University, and a Bachelor of Science (BSc) in Biology/Biological Sciences from Youngstown State University.

Peter Manilla has held key positions in various organizations including being the Founder and Principal Consultant at MANILLA LLC, former Regulatory Affairs personnel at the United States Department of Defense, Director of Regulatory Affairs at VIRxSYS Corporation, Director of Regulatory Affairs at Omrix Biopharmaceuticals, and Manager of Regulatory Affairs at North American Biological Inc (NABI), among many others.

His professional journey also includes roles at AkzoNobel/Organon Teknika Biotechnology Research Institute, Sigma-tau, and as a Consumer Safety Officer at the FDA. Additionally, he has served in the U.S. Army in roles such as USAR Mobilization Designee at the U.S. Army Research Institute of Environmental Medicine, Preventive Medicine Officer in the 2nd Armored Division, and Commander of the 61st Medical Detachment.