Sandra Suarez-Sharp, Ph.D.
Vice President, Regulatory Affairs
Dr. Suarez-Sharp received her Ph.D. from the University of Florida and spent two years as a postdoctoral fellow at the University of North Carolina (Chapel Hill) before joining the U.S. FDA in 1999.
She spent time as a reviewer in the Office of Clinical Pharmacology, Office of Generic Drugs, and Office of Pharmaceutical Quality, where she most recently served as Master Reviewer and Scientific Advisor for the Division of Biopharmaceutics. She was actively involved in the development of many internal procedures for FDA reviewers and guidance documents for industry, and she is recognized as one of the preeminent thought leaders for Physiologically Based Biopharmaceutics Modeling (PBBM).
Her experiences reviewing numerous applications across many offices at the FDA provide her a rare and unique perspective from which your company may now benefit.