Susan Gamble

Susan Gamble, PhD, RAC (US) is an accomplished regulatory affairs professional with extensive experience in leading FDA regulatory activities across various companies. Currently serving as Senior Director of Regulatory Affairs at HighTide Therapeutics, Gamble manages regulatory strategy and operations for both US and Chinese teams. Previous roles include Senior Director at CROMSOURCE, where regulatory and consulting services were provided to sponsors, and Assistant Director at Chiesi Pharmaceuticals, contributing to a 505(b)(2) NDA approval for an antibiotic. Gamble has a strong background in clinical research and has held positions at Supernus Pharmaceuticals, Shire, Sucampo Pharmaceuticals, and Cato Research, where numerous regulatory submissions and clinical development strategies were developed and executed. Gamble has also contributed to academia as Adjunct Faculty at Johns Hopkins University and holds a PhD in Genetics from The George Washington University, along with a Bachelor's degree in Chemistry from Mount Holyoke College.