Jamie Scialdone

Jamie Scialdone is a regulatory affairs professional with extensive experience in establishing and leading regulatory operations teams within the pharmaceutical industry. Currently serving as Senior Director of Regulatory Affairs - Operations at Agios Pharmaceuticals since December 2016, Jamie has focused on the operational management of regulatory documents and submissions. Previously, Jamie held the position of Associate Director of Regulatory Operations at Zafgen, Inc., where the Regulatory Operations function was successfully introduced and processes were developed. Jamie's earlier career at Biogen involved contributions as Manager of Regulatory Operations, playing a key role in implementing a Global Submission Manager role and overseeing multiple programs. Jamie Scialdone holds a Master of Science in Regulatory Affairs for Biologics, Drugs, and Medical Devices from Northeastern University and a Bachelor's degree in Early Childhood Education and Psychology from Bridgewater State University.