Senior Project Manager, Regulatory CMC

Vaxcyte•San Carlos, CA

1d•Hybrid

About The Position

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.

Requirements

BA or BS degree in life sciences, engineering, or business administration; advanced degree desired.
PMP Certification and/or Project Management training desired.
8+ years of experience in the pharmaceutical or biotechnology industry with at least three years of relevant experience in a CMC organization and at least two years directly supporting regulatory submissions, including significant experience in a cross-functional team environment.
Solid understanding of CMC manufacturing and analytical activities required in biotech/drug/vaccine development, including knowledge of cGMP regulations, FDA/ICH regulatory requirements, and eCTD structure (Module 3 CMC content).
Direct experience supporting or leading regulatory filings, including BLA and Prior Approval Supplements (PAS), required.
Demonstrated experience preparing, coordinating, and submitting regulatory filings such as BLA and Prior Approval Supplements (PAS), including managing authoring timelines, cross-functional review cycles, and health authority responses.
Expert analytical skills for integrating and interpreting interdisciplinary project information.
Strong planning and tracking skills, well-organized, focused on results, capable of managing multiple projects with respect to priorities and self-management.
Demonstrated ability to manage complex projects independently and ability to manage changes in processes, strategy, and competitive landscape.
Strong team management skills, including facilitation, conflict resolution, and team development.
Proven influence management and communication skills, at all levels of the organization.
Working knowledge of MS Word, Excel, PowerPoint, Visio, and Project.
Excellent written and oral communication skills.

Nice To Haves

Prior experience as a liaison with external manufacturing organizations desired.
Familiarity with regulatory submission systems and publishing tools (e.g., Veeva Vault RIM/Submissions) a plus.
Working knowledge of Veeva and Smartsheet a plus.

Responsibilities

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 teams.