Jon Harris

Jon Harris is an accomplished regulatory affairs professional with extensive experience in CMC (Chemistry, Manufacturing, and Controls). Currently serving as Executive Director of Regulatory Affairs CMC at Exelixis since June 2025, Harris previously held the role of Senior Director of Regulatory Affairs CMC at IGM Biosciences, Inc. and Bolt Biotherapeutics, Inc. Additionally, Harris served as Associate Vice President and Senior Director of Regulatory Affairs CMC at Omeros Corporation, where responsibilities included developing global regulatory strategies and overseeing execution of regulatory plans. Prior experience includes acting as Senior Director of Regulatory Affairs at AstraZeneca, focusing on biosimilar therapeutics and managing interactions with global health authorities throughout the product lifecycle.