Senior Project Manager, Regulatory CMC

Role: Senior Project Manager, Regulatory CMC, responsible for planning, coordinating, and executing regulatory CMC submissions such as BLAs and Prior Approval Supplements at a clinical-stage vaccine company. Objectives: ensure timely delivery of high-quality regulatory documentation, streamline submission processes, and support regulatory compliance. Responsibilities: develop integrated timelines, manage cross-functional teams, track submission activities, coordinate with external manufacturing partners, and improve workflows. Qualifications: BA/BS in life sciences, engineering, or business; 8+ years in pharma/biotech, with at least three years in CMC and two supporting regulatory submissions; strong knowledge of cGMP, FDA/ICH requirements, and eCTD structure; PMP or project management training preferred. High-Value: vaccine development, biologics, CMC, BLA and PAS filings, regulatory strategy, cross-functional leadership, external vendor management, experience with Veeva Vault or Smartsheet is advantageous. Location: hybrid in San Carlos, CA; work arrangement may be flexible.