I capitalize on 20+ years of international experience in pharma/biotech companies, academic institutions, and consulting organizations to help clients succeed. CAREER HIGHLIGHTS★ Directly contributed to the approval of eight new drug/combination products from major regulatory bodies, including the FDA, totaling over $30 billion in addressable market value.★ Developed and executed regulatory strategies for small molecules, biologics, gene therapies, and combination products in rare and common disease areas, including oncology, ophthalmology, infectious diseases, and neurology.★ Led several regulatory agency interactions, including meetings with FDA (CDER, CBER, and CDRH), EMA, MHRA, TGA, BfArM, Anvisa, SwissMedic, and Health Canada.★ Prepared or evaluated over 100 global regulatory applications, including orphan drug, fast track, breakthrough, RMAT, and rare pediatric disease designations, INDs, CTAs, NDAs, BLAs, MAAs, and post-marketing supplements/variations.★ Authored more than 40 book chapters and articles for peer-reviewed and trade journals. Delivered more than 100 presentations at international conferences, universities, and governmental agencies.★ Turned around a graduate program at a leading University with declining enrollment into one where tuition revenue increased by 800% in five years.★ Received multiple honors and awards, including induction in the Alpha Eta Honor Society for the Health Professions, the TOPRA Award for Regulatory Excellence, the RAPS Community Leadership Award, and the US President’s Volunteer Service Award. ★ Recognized as a Fellow by the Regulatory Affairs Professional Society (FRAPS) and The Organisation for Professionals in Regulatory Affairs (FTOPRA).★ Graduated with a Ph.D. in chemistry from the Swiss Federal Institute of Technology (ETH Zurich).INTERESTS OUTSIDE WORK❖ I enjoy traveling, ethnic food, and playing tennis. ❖ I was born on the Mediterranean coast and learned how to swim before I could walk, but my winter enthusiast and ski-loving husband and son take me to the slopes more often than to the beach. CONTACT ME✉️ Want to discuss working together? Reach out to me here on LinkedIn.