Vice President, Regulatory Affairs

About the role

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

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 sciences, technology, chemistry, or a related discipline, with a specialized degree in regulatory science (e.g., M.S.) or equivalent practical experience
• Regulatory Domain Depth: 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

Core Competencies

• Cross-Functional Collaborator: You work effectively with people of diverse backgrounds and job functions, including clinical, translational, computational, and life scientists
• Motivating Leader: Your interpersonal skills bring out the best in the people around you
• Zero-to-One Builder: 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

Preferred Qualifications

• Computational Regulatory Experience: Exposure to regulatory approvals involving computationally-enabled tools or biomarkers, ideally including AI methods

Compensation & Benefits at insitro

Our target starting salary for successful US-based applicants for this role is $313,000 - $333,000. To determine starting pay, we consider multiple job-related factors including a candidate's skills, education and experience, market demand, business needs, and internal parity. We may also adjust this range in the future based on market data.

This role is eligible for participation in our Annual Performance Bonus Plan (based on company targets by role level and annual company performance) and our Equity Incentive Plan, subject to the terms of those plans and associated policies.

In addition, insitro also provides our employees

• 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 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 insitro is an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.

We believe diversity, equity, and inclusion need to be at the foundation of our culture. We work hard to bring together diverse teams-grounded in a wide range of expertise and life experiences-and work even harder to ensure those teams thrive in inclusive, growth-oriented environments supported by equitable company and team practices. All candidates can expect equitable treatment, respect, and fairness throughout the interview process.

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About insitro insitro is a drug discovery and development company using machine learning (ML) and data at scale to decode biology for transformative medicines. At the core of insitro’s approach is the convergence of in-house generated multi-modal cellular data and high-content phenotypic human cohort data.

We rely on these data to develop ML-driven, predictive disease models that uncover underlying biologic state and elucidate critical drivers of disease.

These powerful models rely on extensive biological and computational infrastructure and allow insitro to advance novel targets and patient biomarkers, design therapeutics and inform clinical strategy. insitro is advancing a wholly owned and partnered pipeline of insights and therapeutics in neuroscience and metabolism.

Since launching in 2018, insitro has raised over $700 million from top tech, biotech and crossover investors, and from collaborations with pharmaceutical partners.