Senior Manager, CMC Regulatory Affairs

Role: Senior Manager of Regulatory CMC overseeing post-approval change management for biopharmaceuticals across diverse modalities, including small molecules and biologics. Responsibilities: lead change control activities, ensure compliance with global regulatory requirements, apply ICH Q12 principles, and implement automation solutions to improve efficiency. Collaborate with manufacturing sites, external partners, and cross-functional teams to align change strategies and facilitate regulatory submissions. Requirements: BS/BA in a scientific discipline, 8+ years in biopharma with at least 5 years in Regulatory CMC, experience with global health authority regulations and Life Cycle Management Systems (e.g., Veeva). Proven ability to develop global regulatory strategies, communicate effectively, and handle complex issues with minimal oversight. Preferred: advanced degree (MS, PhD). HighValue: post-approval change management, global regulatory compliance, ICH Q12, CMC lifecycle, cross-functional collaboration, experience supporting NDA/BLA variations. WorkSetup: based in Wisconsin, no travel specified.