Senior Project Manager, Regulatory CMC

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 teams.

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.
• Prior experience as a liaison with external manufacturing organizations desired.
• 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.
• Familiarity with regulatory submission systems and publishing tools (e.g., Veeva Vault RIM/Submissions) a plus.
• 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.
• Working knowledge of Veeva and Smartsheet a plus.
• Excellent written and oral communication skills.
• All Vaxcyte employees require vaccination against COVID-19.
• Other combinations of education and/or experience may be considered.