Regulatory CMC Project Lead — Biotech Submissions

Regulatory Jobs; San Carlos (CA); Hybrid; USD 166,000 - 195,000; Full time

Job summary

Vaxcyte is seeking a Sr. Project Manager, Regulatory CMC to lead planning, coordination, and execution of regulatory CMC submissions (BLA, PAS) and related activities, partnering with CMC SMEs and external CMOs, reporting to VP, Project Management.

The role emphasizes building integrated timelines, managing cross-functional teams, mitigating risks, and driving submission readiness in a growing biotech environment. Location: San Carlos, CA; Work Arrangement: Hybrid (3 days onsite).

Qualifications

• 8+ years in pharma/biotech with 3+ years in a CMC organization and regulatory submissions experience
• Experience supporting BLA and PAS submissions
• Strong understanding of cGMP, FDA/ICH requirements, and eCTD structure (Module 3 CMC)
• Direct experience liaising with external CMOs and managing authoring timelines
• Familiarity with regulatory submission systems and publishing tools (e.g., Veeva Vault) a plus

Responsibilities

• Lead planning, coordination, and execution of regulatory CMC submissions (BLA, PAS)
• Build and manage integrated submission timelines with cross-functional teams
• Track health authority commitments and post-submission activities
• Develop detailed Reg CMC timelines, identify risks, and communicate actions
• Lead Reg CMC cross-functional meetings and maintain project documentation

Skills

PMP Certification

Project Management

Regulatory submissions

Cross-functional collaboration

BLA knowledge

PAS knowledge

CMC knowledge

Regulatory filings

MS Office

Education

BA/BS in life sciences

Advanced project management training

Tools

Veeva Vault

Smartsheet

Microsoft Office (Word/Excel/PowerPoint)

Job description

Vaxcyte is seeking a Sr. Project Manager, Regulatory CMC to lead planning, coordination, and execution of regulatory CMC submissions (BLA, PAS) and related activities, partnering with CMC SMEs and external CMOs, reporting to VP, Project Management.

The role emphasizes building integrated timelines, managing cross-functional teams, mitigating risks, and driving submission readiness in a growing biotech environment. Location: San Carlos, CA; Work Arrangement: Hybrid (3 days onsite).