Craig Audet, PhD Head, Regulatory Affairs


Head, Regulatory Affairs

Craig M. Audet, Ph.D., is the Head of Regulatory Affairs for South Rampart Pharma,Inc. He has over 30 years of experience in strategic Regulatory planning and support to established and emerging life science companies. His deep Regulatory expertise includes developing and managing content of materials for IND/CTAs, NDA/BLAs, and MAAs. He also has experience with FDA Fast Track, Breakthrough Therapy, Orphan Drug applications, and FDA\EMA meeting requests. Further, he developed Investigator’s Brochures, protocols and amendments, responses to health authorities’ requests for information, DSUR/PSURs, annual reports, and initial and core labeling. He has held previous positions at Pfizer, Sanofi, and Arena Pharmaceuticals. He has been on the faculty of Temple University School of Pharmacy. Dr. Audet received a B.S. from Boston College and Ph.D. from Walden University.