Jim has over three decades of global regulatory experience as an expert in scientific interaction with the U.S. Food and Drug Administration. He provides deep expertise and counsel to RxC and its clients as an Executive Advisor. He has a deep understanding of the regulatory systems in all major markets including US, Europe, and Japan.
Most recently, Jim was the Global Head of Regulatory Affairs and Senior Vice President Regulatory Affairs, Quality Assurance and Risk Management for US and Europe at Daiichi Sankyo. He has served as lead regulatory liaison for major product approvals including: Syprine (one of the first Orphan drugs), Pepcid, Prilosec, Taxotere, Rilutek, Prilosec OTC, Benicar, and Effient. Jim also held positions of increasing responsibility in regulatory affairs, quality assurance, and risk management in major pharmaceutical companies including Merck, RPR, Nycomed, and AstraZeneca.
He holds a Ph.D. in Physiology, with a minor in Statistics from Cornell University, and a B.A. in Biology from Colgate University.