Head of Regulatory
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
- 20+ 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
FAQs
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