Ronald Salerno is a highly experienced Regulatory Affairs professional with a rich background in vaccine, biologics, and drug development spanning 30 years. He has worked on regulatory strategy and product development for FDA IND, BLA, NDA, and MAA application submissions, specializing in CMC Biologics and Vaccines. Mr. Salerno has served as a Regulatory Affairs Affiliate Consultant at Biologics Consulting Group, Inc. since May 2020, where he provided regulatory strategy and CMC submissions support for biologics, gene and cell therapy, and monoclonal antibody therapeutics. Prior to this, he held the position of Senior Consultant at Biologics Consulting Group Inc. for more than a decade from 2008 to 2020, during which he was the CMC Team Leader for CMC Manufacturing and Regulatory Strategy Consultants.

Mr. Salerno's prior experience includes being a Global Regulatory Therapeutic Area Head for Wyeth Vaccines from June 2006 to February 2008, where he led a regulatory group responsible for bacterial and viral vaccines in early development. He also served as a Regulatory Director for Translational Medicine Research and applied Pharmacogenomics biomarkers during the same period. His distinguished career at Merck & Co., Inc., included roles such as Director, Biologics Licensing Quality, where he managed the preparation, submission, and filing strategy for CMC of marketed and developmental vaccines and biologics in the US. He also directed the first marketing authorization of Hepatitis A vaccine during his tenure at Merck.

Ronald Salerno's educational qualifications include a Ph.D. in Zoology, an M.S. in Biology from Villanova University, and a B.A. in Biology from Saint Vincent College.