Cynthia Kirk, Ph.D.
Senior Consultant, Regulatory Strategy
Dr. Cynthia Kirk has over 20 years of Regulatory Affairs experience in Pharma and CRO drug development. She has served as a Senior Executive leading Global Regulatory Affairs Departments with focus on operational efficiencies and quality in small to large Pharma and Contract Research Organizations (CROs). She has experience as sponsor liaison (Agent) to FDA, negotiating development and approvals for OTC and prescription drug products including ChloraPrep® Lunesta®, Ketek®, Priftin®, Nilandron®, Allegra®, Allegra D®, Pentasa®, and Carafate® Suspension.
Cindy has extensive experience as project team facilitator for various FDA interactions including meeting coordination and preparation for pre-IND/IDE, End of Phase 1, End of Phase 2, Pre-NDA meetings and labeling negotiations. In addition to her roles in the industry, Cindy has also been very active in Trade Associations, serving as President and Board member for Drug Information Association (DIA) elected 2003-2008.
Dr. Kirk has received numerous awards for her service to the industry, including the DIA Excellence in Leadership Award in 2009, the Regulatory Affairs Professional Society Leonard Stauffer Award in 2002, and the DIA Outstanding Service Award in 2002. She has also served as Faculty for DIA Regulatory Training Courses since 1997.
Dr. Kirk has a bachelors degree in Natural Sciences/Chemistry from Stephens College and a Ph.D. in Pharmacology/Toxicology from the University of Missouri – Kansas City. She joined Catalyst Regulatory Services as a Senior Consultant in 2012.