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Job description
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
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Worksite address
san francisco, CA, 94199, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.