Amicus Therapeutics
Executive Director CMC Regulatory
Saroj Ramdas is the Director of CMC Biopharm Regulatory Advocacy, Strategy, and Policy at GlaxoSmithKline, based in Collegeville, Pennsylvania. She leads activities focused on external engagement related to CMC topics, drives strategic approaches from a regulatory perspective to enhance CMC development, and facilitates GSK’s input regarding CMC-related policy. Saroj has 22 years of experience in drug product development, sterile manufacturing, and CMC regulatory advocacy. She has developed an in-depth knowledge regarding sterile drug product formulation, technology transfer, commercial manufacturing, regulatory documentation, QbD, and accelerated development strategies. She is an active member of various external organizations, including PhRMA, Alliance for Regenerative Medicine (ARM), BioPhorum, BIO, and IQ Consortium (Bio LG). She has been an ISPE member since 2020.
