Her experience covers over 18 years in the pharmaceutical drug development field in which she has assisted international companies in obtaining licensing agreements with the USA Food & Drug Administration. Previously she served as regulatory project manager at the FDA and gained extensive experience and knowledge in all phases of the regulatory process leading to marketing authorization. Specialized FDA experience with experience coordinating and leading scientific projects in collaboration with regulatory staff and multidisciplinary, matrix designed teams, to include clinicians, chemists, biologists, toxicologists, pharmacologists, and/or statisticians, in the drug review process; and ensuring legal, regulatory and policy requirements/compliance associated with drug development.
Prior to her FDA position, she served in several clinical operations project management roles providing customer-focused leadership, in all phases of drug development.
She holds a R.N. degree and a M.S.H.S. in clinical research administration from the George Washington University in Washington D.C.
She is a Member of the Alpha Eta Honor Society, a prestigious American national honor society, as recognition of leadership capabilities and high attainments in the health professional field.