Vice President, Regulatory Affairs

📋 Description

• Lead regulatory function across three therapeutic areas and modalities
• Develop global regulatory strategies for small molecules, biologics, and diagnostics
• Role can be onsite 3 days/wk in South San Francisco or hybrid ~1 week/mo
• Interface with FDA, EMA, and global authorities; ensure regulatory compliance
• Drive risk mitigation and data-driven go/no-go decisions
• Shape AI/ML regulatory landscape and policy engagement

🎯 Requirements

• 10+ years in regulatory affairs in biotech/pharma
• Clinical delivery track record from first-in-human to NDA/BLA
• Advanced life sciences degree; regulatory science specialization preferred
• Strong command of GxP, trial design, pharmacology, biostatistics
• Cross-functional leadership and startup-building experience
• Computational regulatory experience with AI/machine learning a plus

🎁 Benefits

• Salary: $313,000 – $333,000 (USD)
• Annual bonus plan and equity incentives
• 401(k) with employer match; comprehensive health benefits
• Flexible vacation; paid parental leave; learning stipend
• Home office setup stipend and stipends for mobile/internet
• Commuter bus access to South San Francisco HQ