Job Title

Provide strategic leadership in Regulatory Affairs CMC for biologics. Oversee regulatory submissions and lifecycle management while mentoring a high-performing team. This pivotal role involves directing regulatory activities for biologics submissions, including INDs and BLAs. You will collaborate closely with management and cross-functional teams to shape regulatory strategies and ensure compliance with health authorities. Drive post-approval change management and foster a culture of excellence in your team while managing client relationships. Key Responsibilities: Direct all CMC regulatory activities for biologics Oversee regulatory submission processes significantly Advise project teams on key regulatory issues Support agency meetings and health authority interactions Mentor and develop team members for success Requirements: 1015 years in direct CMC Regulatory Affairs Educational background in biological or pharmaceutical fields Proven experience with Module 3 and submissions Strong leadership and mentoring experience Deep knowledge of FDA CMC requirements Enhance your career by driving regulatory excellence in a challenging biologics environment. #J-18808-Ljbffr