Ethan O'Malley

Ethan O'Malley is a seasoned professional in the field of regulatory affairs, currently serving as the Senior Director of Regulatory Affairs CMC at Ultragenyx Pharmaceutical Inc. since May 2022, where responsibilities include leading multiple late stage AAV gene therapy programs and strategic FDA interactions. Previous roles include Head of CMC Regulatory Strategy and CMC Writing at bluebird bio and Director of Regulatory CMC at Vertex Pharmaceuticals, overseeing direct reports and managing post-approval marketed programs. O'Malley's career includes strategic leadership at Shire and Biogen, focusing on cross-functional teams and innovative regulatory strategies. With a foundational background starting at Vertex Pharmaceuticals and Repligen in peptide chemistry and GMP manufacturing, O'Malley holds an MBA in International Business from Suffolk University and a BS in Biology from UMass Boston.