Fang Li, Ph.D., RAC, is Vice President, Regulatory Affairs at Hurley Consulting. She has worked in the pharmaceutical industry for over 20 years. Dr. Li has extensive experience with product development and launch, health authority interactions, FDA advisory committee meeting preparation, business development, and building and leading regulatory teams. She has a proven success record in negotiating and gaining product approvals in the US and other regions. Dr. Li is recognized for her strategic input for critical paths in product development and awareness of the marketing landscape to develop the best regulatory strategy to allow competitiveness of products to meet patient needs. She has an in-depth understanding of drug development and the expertise to provide input in CMC, nonclinical, clinical, launch preparation and compliance. Her experience and expertise includes small molecules, biologics, gene therapy, over-the-counter products, in vitro diagnostic products, and medical devices.
As Vice President, Regulatory Affairs, at Hurley Consulting, Dr. Li is responsible for regulatory strategy, regulatory management of product development, critical review of submission documents, and general regulatory activities related to preparation of client document and submissions. She advises clients on regulatory strategy, and at their request, Dr. Li represents sponsors with FDA and other health authorities to facilitate review and approval of product applications and resolution of regulatory issues.
Before joining Hurley Consulting, Dr. Li was a consultant for the pharmaceutical and biotech industries. She was Vice President, Regulatory Affairs, at Iveric Bio, Inc. She has also held positions as Global Program Regulatory Director at Novartis, Pharmaceuticals, Inc., and other positions in regulatory affairs at Thrombogenics Inc, Bausch + Lomb Inc., Columbia Laboratories Inc., and Warner Chilcott Inc. Dr. Li began her career as a research scientist. This work included breast cancer research at Strang Cancer Prevention Center/Cornell University Weill Medical School. She has also provided product support for chemistry and manufacturing in pharmaceutical and diagnostics product development.
She holds a doctoral degree in medicinal chemistry from China Pharmaceutical University, Nanjing, P. R. China; a master's degree in organic chemistry from Wuhan University, P. R. China; and a bachelor's degree in organic chemistry from Xiamen University, P. R. China. She was a Carl Monder Fellow at The Population Council. Dr. Li has been RAC US certified since 2005, and she co- chaired the NY/NJ Chapter of the Regulatory Affairs Professional Society (RAPS) in 2014 and 2015.