Sr. Associate Regulatory Affairs

Amgen is hiring a Regulatory CMC staff member to support product development and global registrations by executing regulatory strategies and managing regulatory interactions for manufacturing and quality programs across the product lifecycle. The role is part of the ROOTS2 team in India, supporting CMC and Device submission execution across development phases, modalities, and countries. The position interfaces with global, site, biosimilars, and device RA CMC teams and provides varying levels of product support, including project leadership based on experience.