Sabrina Gu

Sabrina has more than 15 years of comprehensive Regulatory Affairs, operations, and management experience in biotechnology, pharmaceutical, and medical device companies.  Sabrina’s experience spans multiple therapeutic modalities, including small molecules, proteins, cell and gene therapies, and medical devices, and includes establishing internal guidelines as well as knowledge of the guidance and regulations necessary for effective operation in a regulatory environment. Her experience includes regulatory strategy development for early-stage to commercial programs, inclusive of dossier composition and review, and supervising multidisciplinary teams in the submission of INDs/CTAs as well as marketing applications globally.  Sabrina previously held the position of Sr. Director of Regulatory Affairs at BioMarin Pharmaceuticals and held prior positions of increasing responsibility at The Medicines Company, ProFibrix, and Dendreon.  Sabrina received an undergraduate degree in Human Biology from Scripps College, completed postgraduate training at Harvard University, and received her M.S. in Biomedical Regulatory Affairs from the University of Washington.