Senior CMC Regulatory Affairs Manager

The Senior CMC Regulatory Affairs Manager at AbCellera will work closely with Manufacturing and Quality teams to implement and document global CMC strategies for multiple biologics programs, from pre-clinical development through Phase 3 studies and commercialization. This role involves leading the planning, authoring, and execution of global CMC regulatory submissions, providing strategic regulatory guidance, and managing critical timelines to ensure compliance with global health authority requirements. The position requires a deep understanding of CMC regulatory requirements, eCTD structure, and experience in Module 3 preparation for biologics and combination products.