Vice President, Regulatory Affairs

THE OPPORTUNITY

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.

RESPONSIBILITIES

Regulatory Strategy & Leadership

- Lead the Function: Own the entire regulatory function across three therapeutic areas, diverse modalities, and novel laboratory and digital biomarkers, both internally developed and in-licensed

- Design Innovative Strategies: Build regulatory approaches that enable objective, data-driven go/no-go decisions and shorten the development cycle in an evolving landscape

- Serve as Global Regulatory Lead: 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

Submissions & Health Authority Engagement

- Own End-to-End Strategy: Be accountable for global regulatory strategy from IND/CTA through clinical proof-of-concept, spanning diverse regulatory pathways

- Drive Submissions: Direct the creation, review, assembly, and submission of INDs, CTAs, NDAs, BLAs, and MAAs across clinical, CMC, device, and nonclinical functions

- Engage Authorities: 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

- Mitigate Risk: Identify and address regulatory risks before they become development delays

Shaping the AI/ML Regulatory Landscape

- Influence Emerging Policy: Shape regulatory policy for artificial intelligence and machine learning through original publications, presentations, and stakeholder engagement

- Translate for Leadership: Interpret regulatory requirements for project teams, the executive team, the board of directors, and the scientific advisory board

ABOUT YOU

Experience & Qualifications

- Proven Tenure: 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

- Clinical Delivery Track Record: 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

- Education: Advanced degree in life scie …