Jiwen Chen is Global Regulatory Affairs Lead at Sobi, where he is responsible for the regulatory CMC strategies of marketed products and late-stage investigational drugs. Prior to his current role, he spent more than a decade at Bristol Myers Squibb, contributing to the development of several medicines on the market. He is an active volunteer for AAPS, having served in the CMC community in the past three years. He holds a Ph. D. in analytical chemistry from the University of Nebraska.