Job Details

Location: San Francisco Bay Area (Onsite/Hybrid preferred)

Compensation: $300,000-$400,000 base salary

About the Company

Our client is an early-stage, biotech operating in stealth mode. This is a rare opportunity to join at the ground floor and shape both the regulatory function and broader development strategy.

The Role

We're looking for a Head of Regulatory Affairs (VP/SVP) who can build the regulatory organization from scratch, set strategy, and operate with urgency and clarity. This person should be equal parts builder, strategist, and hands-on leader. Someone who can run alongside a growing team and lead a pack of high performers in a fast-moving environment.

Key Responsibilities

• Own global regulatory strategy across early development, with initial focus on preparing and filing INDs
• Build and scale the regulatory function, including hiring, vendor oversight, and establishing systems, processes, and infrastructure
• Partner cross-functionally with Clinical Development, CMC, Nonclinical, and executive leadership to align development milestones and regulatory pathways
• Lead interactions with FDA and other health authorities; prepare briefing packages and orchestrate agency meetings
• Drive submission planning and execution for IND, amendments, and future clinical/marketing applications
• Provide guidance on regulatory risks, timelines, and decision-making across the portfolio
• Ensure compliance and maintain a culture of quality from day one

What We're Looking For

• 15+ years of regulatory affairs experience within biotech/pharma
• Demonstrated success leading IND filings and early-phase regulatory strategy
• Experience building regulatory capabilities from the ground up (team, systems, processes)
• Strong background in oncology; biologics experience is highly preferred
• Proven ability to lead, influence, and operate in a resource-lean, fast-paced startup environment
• Comfortable being both strategic and execution-focused. Roll your sleeves up, builder mentality

Why Join

• Foundational leadership role in a company entering an exciting phase of growth
• High impact, high visibility, directly shaping development strategy and organizational build
• Opportunity to work with a strong scientific and clinical leadership team
• Competitive compensation, equity, and the ability to create something meaningful from day one