Vice President Regulatory Affairs

Location: San Francisco Bay Area (Onsite/Hybrid preferred)Compensation: $300,000-$400,000 base salaryAbout the CompanyOur 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 RoleWe'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 ResponsibilitiesOwn global regulatory strategy across early development, with initial focus on preparing and filing INDsBuild and scale the regulatory function, including hiring, vendor oversight, and establishing systems, processes, and infrastructurePartner cross-functionally with Clinical Development, CMC, Nonclinical, and executive leadership to align development milestones and regulatory pathwaysLead interactions with FDA and other health authorities; prepare briefing packages and orchestrate agency meetingsDrive submission planning and execution for IND, amendments, and future clinical/marketing applicationsProvide guidance on regulatory risks, timelines, and decision-making across the portfolioEnsure compliance and maintain a culture of quality from day oneWhat We're Looking For15+ years of regulatory affairs experience within biotech/pharmaDemonstrated success leading IND filings and early-phase regulatory strategyExperience building regulatory capabilities from the ground up (team, systems, processes)Strong background in oncology; biologics experience is highly preferredProven ability to lead, influence, and operate in a resource-lean, fast-paced startup environmentComfortable being both strategic and execution-focused. Roll your sleeves up, builder mentalityWhy JoinFoundational leadership role in a company entering an exciting phase of growthHigh impact, high visibility, directly shaping development strategy and organizational buildOpportunity to work with a strong scientific and clinical leadership teamCompetitive compensation, equity, and the ability to create something meaningful from day one