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.
Reports to: Vice President, Project Management
Location: San Carlos, CA
Work Arrangement (may be adjusted based on business needs, job responsibilities, or changes to company policy): Hybrid (3 days per week onsite)
Compensation:The compensation package will be competitive and includes comprehensive benefits and an equity component.
Salary Range: $166,000 - $195,000 (SF Bay Area). Salary ranges for non-California locations may vary.
