Vice President of Product Development
Dr. Kozarek has 29 years industrial experience and 9 years consulting to the pharmaceutical industry. He has held drug development management positions for Analytical Chemistry, Biopharmaceutics, Clinical Pharmacy, Formulation Development, Contract Manufacturing, Licensing and Acquisition, and Regulatory Organizations. Dr. Kozarek has extensive experience in Rx and OTC drugs. He has played key roles in the Rx to OTC switch of Prilosec, Aleve, and Femstat. Dr. Kozarek has participated in over 30 IND programs and 12 NDA programs including 8 original NDAs and 2 ANDAs, numerous FDA meetings and advisory panels. Dr. Kozarek is the President of Kozarek Regulatory Consulting, Inc. Dr. Kozarek received a Ph.D. in Analytical Chemistry from the University of Arizona and has been an adjunct professor at the University of Cincinnati, School of Pharmacy.