R. Wayne Wiley, RPh Vice President, Regulatory Affairs and Pharmacovigilance
R. Wayne Wiley brings more than 30 years of experience in pharmaceutical regulatory affairs to Recro Gainesville, serving as the site’s vice president of regulatory affairs and pharmacovigilance. Wayne is an experienced manager with broad experience and success providing support for regulatory agency meetings in addition to IND, NDA, ANDA, DMF, and ROW filings and approvals. Wayne has a strong understanding of regulatory, clinical, development, and life cycle management filing requirements, including post approval support for phase IV, pharmacovigilance, and supplemental approvals.
Prior to joining Recro, Wayne held various positions of increasing responsibility at Alkermes, Elan Drug Technologies, and Solvay Pharmaceuticals.
Wayne is a registered pharmacist, graduating from the Mercer University School of Pharmacy. He has delivered lectures in regulatory affairs and pharmacovigilance for the University of Georgia School of Pharmacy: Master of Science in Regulatory Affairs program and serves on the curriculum and admissions committees. He has also provided support for the Mercer School of Pharmacy: Doctor of Pharmacy Preceptor training program. He is a member of RAPS, DIA, and AAPS.