Vice President Regulatory Affairs

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