Senior Project Manager, Regulatory CMC

About the Role

Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from bacterial diseases. This role will serve as a key contributor to the company’s project management, regulatory, and CMC functions, reporting to the Vice President, Project Management. The Sr. Project Manager, Regulatory CMC 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.

Our work is guided by four enduring core values:

• Rethink Convention: We bring creative and intellectual diversity to innovate and re-innovate vaccine delivery.
• Aim High: We courageously tackle the most complex biologics to protect humankind.
• Lead with Heart: We foster a kindness-first, inclusive approach to collaboration and vigorous debate.
• Model Excellence: We demonstrate integrity, accountability, equality, and clarity in communications and decision-making.

Responsibilities

• Project management for the planning, coordination, and execution of regulatory CMC submissions (e.g., BLAs, Prior Approval Supplements), 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/review cycles, and publishing schedules.
• Track health authority commitments and post-submission activities; coordinate cross-functional teams to ensure timely, high-quality responses.
• Develop detailed Reg CMC timelines, identify risks, and communicate/escalate to align deliverables with product/project goals.
• Lead Reg CMC cross-functional meetings, including scheduling, agendas, meeting summaries, documentation, and action-item tracking.
• Communicate project status, activities, and risks to stakeholders and leadership.
• Contribute to cross-functional working plans, prioritize workstreams, mitigate risks, and ensure resourcing for program goals.
• Build and manage trackers/dashboards to communicate real-time submission status and interdependencies with manufacturing/analytical readiness.
• Manage regulatory submission authoring/review with external CMOs via Statements of Work (SOWs), including execution and deliverable tracking.
• Identify and implement process/tools to streamline Reg CMC project management and submission workflows.

Requirements

• BA/BS in life sciences, engineering, or business administration; advanced degree desired.
• PMP Certification and/or Project Management training preferred.
• 8+ years in pharmaceutical/biotechnology, with ≥3 years in a CMC organization and ≥2 years supporting regulatory submissions (e.g., BLA, PAS) in cross-functional teams.
• Solid understanding of CMC manufacturing/analytical activities, cGMP regulations, FDA/ICH requirements, and eCTD structure (Module 3 CMC content).
• Direct experience supporting/leading regulatory filings (BLA, PAS) and managing authoring timelines, review cycles, and health authority responses.
• Experience liaising with external manufacturing organizations preferred.
• Familiarity with regulatory submission systems/tools (e.g., Veeva Vault RIM/Submissions) a plus.
• Expert analytical skills for integrating interdisciplinary project information.
• Strong planning, tracking, and self-management skills; ability to prioritize multiple projects.
• Proven ability to manage complex projects independently and adapt to process/strategy changes.
• Strong team management skills, including facilitation, conflict resolution, and team development.
• Proficient in MS Word, Excel, PowerPoint, Visio, and Project; Veeva/Smartsheet a plus.
• Excellent written/oral communication skills.
• COVID-19 vaccination required for all employees.

Other combinations of education/experience may be considered.

Location & Schedule

San Carlos, CA. Hybrid work arrangement (3 days per week onsite, subject to business needs).

Pay

Salary range: $166,000–$195,000 (SF Bay Area). Ranges for non-California locations may vary. Competitive compensation package includes comprehensive benefits and equity.