Vice President, Regulatory Affairs
About The Position
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. With multiple programs in metabolic disease and neuroscience advancing toward the clinic, and our first IND submission slated for the second half of this year, we are at a pivotal inflection point. 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 our three therapeutic areas: neurology/neurodegeneration, metabolism/cardiovascular, and ophthalmology. This is a founding role: you will be insitro's first dedicated regulatory leader, shaping the function's strategy, systems, and team as our first programs reach the clinic. The application of AI and machine learning to diagnostics and drug development is accelerating, and regulatory science is catching up in real time. You will be at the forefront of implementing and influencing new regulatory policy across multiple jurisdictions using objective, data-driven approaches, treating health authorities as key partners who share our vision of bringing better, more targeted drugs to patients faster. This role can be either onsite three days per week in our South San Francisco office or hybrid at roughly one week per month, with additional travel to medical and regulatory science conferences and health authority engagements.
Requirements
- 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 the regulations and guidelines governing drug, diagnostic, and device development, including good clinical practice, clinical trial design and execution, clinical pharmacology, biostatistics, and clinical operations
- You work effectively with people of diverse backgrounds and job functions, including clinical, translational, computational, and life scientists
- Your interpersonal skills bring out the best in the people around you
- You are energized by standing up a function where none exists — writing the first SOPs yourself while setting the strategy for a department that doesn't exist yet
Nice To Haves
- Exposure to regulatory approvals involving computationally-enabled tools or biomarkers, ideally including AI methods
Responsibilities
- Own the entire regulatory function across three therapeutic areas, diverse modalities, and novel laboratory and digital biomarkers, both internally developed and in-licensed
- Build regulatory approaches that enable objective, data-driven go/no-go decisions and shorten the development cycle in an evolving landscape
- Personally lead regulatory strategy for our initial clinical-stage assets, then hire and manage a focused team of global regulatory leads as the pipeline grows
- 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
- Shape regulatory policy for artificial intelligence and machine learning through original publications, presentations, and stakeholder engagement
- Interpret regulatory requirements for project teams, the executive team, the board of directors, and the scientific advisory board
Benefits
- Annual Performance Bonus Plan
- Equity Incentive Plan
- 401(k) plan with employer matching
- Medical, dental, and vision coverage
- Mental health and well-being support
- Open, flexible vacation policy
- Paid parental leave of at least 16 weeks to support parents who give birth, and 10 weeks for a new parent (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 that provides transport to and from our South San Francisco HQ from locations all around the Bay Area
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What This Job Offers
Job Type
Full-time
Career Level
Executive
