During her 30-year career in regulatory affairs, Dr. Church has worked with all reviewing CDER and CBER Divisions of the FDA and has had regulatory oversight for 27 New Drug Applications and over 140 INDs/CTXs. Previously, she held various management positions in the areas of regulatory affairs, quality assurance, clinical affairs, and project management for Pfizer Global Research and Development, Ancile Pharmaceuticals, Advanced Bioresearch Associates, InSite Vision, Gensia, Hoffmann-LaRoche, Abbott Laboratories and Astra Pharmaceuticals. Dr. Church is a former president of the Drug Information Association (DIA) and a previous Chair for the DIA’s Steering Committee for the Americas. |