Sr. Manager of Regulatory Affairs, Biologicals and Chemicals

The Sr. Manager of Regulatory Affairs will provide strategic regulatory leadership for pharmaceutical ancillary materials and excipients, developing detailed drug support strategies to ensure safe and compliant handling. This role involves collaborating with cross-functional teams to execute company priorities, driving initiatives aligned with global strategies, and developing world-class regulatory support. Responsibilities include interpreting global regulations, assessing product changes, planning ex-US registrations, leading regulatory affairs talent, supporting customer due diligence, handling regulatory documentation requests, and serving as a point of contact for marketing, sales, and training teams. The manager will also establish regulatory demands, provide strategic mentorship on CMC regulatory submissions, ensure scalable and consistent regulatory solutions, coordinate with global counterparts, develop training programs, and lead initiatives to harmonize processes for supporting pharmaceutical customers.