Vice President, Regulatory Affairs

About the Role

insitro is a physical AI company dedicated to unlocking causal human biology and accelerating the delivery of better medicines to patients. Our unique Virtual Human™ platform identifies novel, high-impact genetic intervention points, which our TherML™ platform translates into therapeutics—whether small molecules, biologics, or oligos. We are seeking a Vice President of Regulatory Affairs to build our regulatory function from the ground up. Reporting directly to the Chief Medical Officer, you will develop and implement global regulatory strategies supporting multiple therapeutics (small molecules, biologics, and oligonucleotides) and diagnostics across neurology/neurodegeneration, metabolism/cardiovascular, and ophthalmology.

This is a founding role: you will shape the function's strategy, systems, and team as our first programs reach the clinic. The role can be either onsite three days per week in our South San Francisco office or hybrid (one week per month), with additional travel to medical and regulatory science conferences and health authority engagements.

Responsibilities

• Regulatory Strategy & Leadership
  • Own the entire regulatory function across three therapeutic areas, diverse modalities, and novel laboratory and digital biomarkers.
  • Design innovative regulatory approaches to enable objective, data-driven go/no-go decisions and shorten the development cycle.
  • Serve as the global regulatory lead for initial clinical-stage assets, then hire and manage a team of global regulatory leads as the pipeline grows.
• Submissions & Health Authority Engagement
  • Be accountable for global regulatory strategy from IND/CTA through clinical proof-of-concept, spanning diverse regulatory pathways.
  • Direct the creation, review, assembly, and submission of INDs, CTAs, NDAs, BLAs, and MAAs across clinical, CMC, device, and nonclinical functions.
  • Serve as the primary interface with FDA and EMA, oversee interactions with other global health authorities and ethics committees, and ensure adherence to good clinical practice and regulatory standards.
  • Identify and address regulatory risks before they become development delays.
• Shaping the AI/ML Regulatory Landscape
  • Shape regulatory policy for artificial intelligence and machine learning through original publications, presentations, and stakeholder engagement.
  • Translate regulatory requirements for project teams, the executive team, the board of directors, and the scientific advisory board.

Requirements

• Experience & Qualifications
  • 10+ years of experience in regulatory affairs in the biotechnology and/or pharmaceutical industries, including time directly as a regulatory lead and in a leadership role.
  • Experience taking therapeutics and diagnostic biomarkers from first-in-human through proof-of-concept to NDA/BLA submission in metabolic disease, neurology/neurodegeneration, or oncology.
  • Advanced degree in life sciences, technology, chemistry, or a related discipline, with a specialized degree in regulatory science (e.g., M.S.) or equivalent practical experience.
  • Demonstrated command of regulations and guidelines governing drug, diagnostic, and device development, including good clinical practice, clinical trial design and execution, clinical pharmacology, biostatistics, and clinical operations.
• Core Competencies
  • Cross-functional collaborator: work effectively with people of diverse backgrounds and job functions, including clinical, translational, computational, and life scientists.
  • Motivating leader: interpersonal skills that bring out the best in others.
  • Zero-to-one builder: energized by standing up a function where none exists—writing the first SOPs while setting the strategy for a new department.

Preferred Qualifications

• Exposure to regulatory approvals involving computationally-enabled tools or biomarkers, ideally including AI methods.

Benefits

• 401(k) plan with employer matching for contributions.
• Excellent medical, dental, and vision coverage, as well as mental health and well-being support.
• Open, flexible vacation policy.
• Paid parental leave of at least 16 weeks for birth parents and 10 weeks for new parents (inclusive of birth, adoption, fostering, etc.).
• Quarterly budget for books and online courses for self-development.
• New hire stipend for home office setup.
• Monthly cell phone & internet stipend.
• Access to free onsite baristas and daily lunch for employees who are either onsite or hybrid.
• Access to a free commuter bus network providing transport to and from our South San Francisco HQ from locations around the Bay Area.

Pay

Target starting salary for successful US-based applicants: $313,000 - $333,000. This role is eligible for participation in our Annual Performance Bonus Plan and Equity Incentive Plan, subject to the terms of those plans and associated policies.