Senior Specialist, CMC Regulatory Affairs

Senior Specialist, CMC Regulatory Affairs

Our client, a Clinical-Stage Cell Therapy company, is looking for a Senior Specialist, CMC Regulatory Affairs for their Seattle, WA / Bothell, WA / Hybrid location. Responsibilities : Support preparation, review, and submission of CMC sections for U.S. and global regulatory filings, including INDs / CTAs, amendments, and BLAs / MAAs. Coordinate with internal stakeholders to gather technical...