Senior Director Regulatory Affairs, CMC

Job description

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer. BeOne is seeking an accomplished and highly influential regulatory leader to head the U.S. Biologics Regulatory CMC organization. This role provides strategic and operational leadership for U.S.-based biologics Regulatory CMC activities and serves as a key partner to the China-based counterpart and global cross-functional stakeholders in the development and execution of global CMC regulatory strategies across the product lifecycle. The scope of responsibility includes, but is not limited to, monoclonal antibodies, antibody–drug conjugates (ADCs), cell therapies, and medical device–combination products. The role has accountability for CMC-related regulatory submissions and health authority interactions, ensuring high-quality, compliance, and timely filings that support clinical development, licensure, and post-approval lifecycle management. This leader will lead and continuously op...