Senior Manager, CMC Regulatory Affairs

The Senior Manager, CMC Regulatory Affairs will work with Manufacturing and Quality teams to implement and document global CMC strategies for multiple biologics programs, from pre-clinical development through commercialization. This role involves leading the planning, authoring, and execution of global CMC regulatory submissions, providing strategic guidance, and managing critical timelines to ensure compliance with global health authority requirements. The position requires collaboration with cross-functional project teams to shape regulatory strategies and ensure timely, high-quality submissions.