Senior Project Manager, Regulatory CMC

Join our Mission to Protect Humankind! Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and costly health consequences when left unchecked. Working to eradicate or treat bacterial infections such as invasive pneumococcal disease, Group A Strep, and Shigella is just the beginning. Our path to success is clear and well-defined, and Vaxcyte is set up to go the distance. WHAT we do is every bit as important as HOW we do it! Our work together is guided by four enduring core values: *RETHINK CONVENTION: We bring creative and intellectual diversity to every facet of the work we do in order to innovate and re-innovate the way vaccines are delivered. *AIM HIGH: We embody our collectively audacious goal to courageously make the most complex biologics ever attempted to protect humankind. *LEAD WITH HEART: Everyone leads at Vaxcyte with a kindness-first, inclusive approach to collaboration and vigorous debate that advances our business objectives. *MODEL EXCELLENCE: The magnitude of our challenge requires our shared commitment to demonstrating integrity, accountability, equality and clarity across communications and decision making. Summary: The Sr. Project Manager, Regulatory CMC will serve as a key contributor to the company’s project management, regulatory and CMC functions. Reporting to the Vice President, Project Management, this role will be highly hands-on, owning the planning, coordination, and execution of regulatory CMC submissions — including BLAs and Prior Approval Supplements — while partnering closely with CMC subject matter experts and external manufacturing partners. This role is ideal for a detail-oriented project management professional who enjoys building integrated timelines, driving cross-functional alignment, and helping streamline submission processes in a growing biotechnology company. Essential Functions: Project Management for the planning, coordination, and execution of regulatory CMC submissions, including Biologics License Applications (BLA), Prior Approval Supplements (PAS), and other regulatory filings, ensuring cross-functional CMC content is authored, reviewed, and delivered on schedule. Partner with Regulatory and CMC subject matter experts to build and manage integrated submission timelines, authoring and review cycles, and publishing schedules for BLA, PAS, and supplemental regulatory filings. Track health authority commitments and post-submission activities and coordinate cross-functional teams to ensure timely, high-quality responses. Develop detailed Reg CMC timelines, identify risks and mitigating actions and communicate/escalate accordingly to ensure clarity of deliverables and timing to achieve overall product/project plan and corporate goals/objectives. Lead Reg CMC cross-functional meetings, including scheduling and facilitating meetings, sending out agendas, writing and distributing meeting summaries, managing team documentation, and tracking goals and action items. Communicate with appropriate stakeholders to ensure project team and leadership are fully informed and knowledgeable of project activities, status, and potential risks. Contribute to program cross-functional working plans and timelines, help teams prioritize workstreams, proactively identify and mitigate risks, and ensure sufficient resourcing to achieve program goals. Build and manage trackers and dashboards to communicate real-time status of regulatory submissions and the interdependencies with campaign manufacturing and analytical readiness, release and downstream use. Manage regulatory submission authoring and review with external CMOs through development of Statements of Work (SOW) contracts. Manage execution of SOWs and track progress and completion of deliverables. Identify and implement processes/tools to continuously improve and streamline the workflow of Reg CMC project management and submission te…