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Vaxcyte is a clinical-stage vaccine innovation company developing high-fidelity vaccines to protect against bacterial diseases including invasive pneumococcal disease, Group A Strep, and Shigella. The Senior Project Manager, Regulatory CMC will serve as a key contributor to the company's project management, regulatory, and CMC (Chemistry, Manufacturing, and Controls) functions, reporting to the Vice President of Project Management.
This is a highly hands-on role owning the planning, coordination, and execution of regulatory CMC submissions, including Biologics License Applications (BLAs) and Prior Approval Supplements (PAS). You will partner closely with CMC subject matter experts and external manufacturing partners to build integrated timelines, drive cross-functional alignment, and streamline submission processes.
Key responsibilities include: developing and managing detailed regulatory CMC timelines with risk identification and mitigation strategies; partnering with regulatory and CMC experts to coordinate submission authoring, review cycles, and publishing schedules; tracking health authority commitments and post-submission activities; leading cross-functional meetings and managing team documentation; communicating project status and risks to stakeholders and leadership; contributing to program-wide working plans and resource prioritization; building trackers and dashboards for real-time submission status visibility; managing external CMO relationships through SOW contracts; and identifying process improvements to streamline regulatory submission workflows.
The ideal candidate is detail-oriented, enjoys building integrated timelines, and thrives in a growing biotechnology environment. You will need 8+ years of pharmaceutical or biotech industry experience, with at least 3 years in a CMC organization and 2+ years directly supporting regulatory submissions. A solid understanding of cGMP regulations, FDA/ICH requirements, eCTD structure, and direct experience with BLA and PAS filings is required. Prior experience as a liaison with external manufacturing organizations is desired. A BA/BS in life sciences, engineering, or business administration is required; an advanced degree is desired. PMP certification or project management training is a plus.
