Mark Levi

Mark Levi is an expert in biopharma regulatory affairs with passion for U.S. regulatory strategy and international harmonization. He is an expert in biologics, cell therapy, monoclonal antibodies, vaccines, gene therapy, pharmacology, data integrity, biologic-device combination products, neurotoxicology, and regulatory and product development strategy.

Dr. Levi joined RTI in 2022. Prior, he served as an FDA reviewer and regulatory project manager. He was also a director of regulatory affairs at a late-stage biotech industry and a senior consultant at a large contract research organization. In addition to his work, Dr. Levi has professional affiliations with the New Zealand Institute of Chemistry and the Regulatory Affairs Professionals Society (RAPS).