Courtney Newberg

Courtney Newberg is an experienced regulatory affairs professional with a strong background in Chemistry and Forensic Science. Currently serving as Senior Manager CMC Regional Regulatory Lead at Biogen since January 2023, Courtney is responsible for determining regulatory CMC strategy for various global markets and leading submission and compliance activities. Previous roles include Manager Regulatory Affairs CMC at Genpact, where Courtney provided regulatory strategy input and supported global submissions, and Senior Regulatory Affairs Associate at Takeda, focusing on project management for critical regulatory applications in the U.S. Additional experience encompasses regulatory submissions and compliance at Hikma Pharmaceuticals and Mylan, as well as foundational work as a Quality Control Chemist and Forensic Analyst. Courtney holds a Bachelor of Science degree in Forensic Science from Waynesburg University.