Insitro

Insitro

Vice President, Regulatory Affairs

South San Francisco, CA · Exec

Sponsorship not specified$313k-$333kDetected 59 days ago
Machine LearningPharmacologyFDA RegulatoryLeadershipCommunicationPublic SpeakingGxPBiostatisticsRegulatory Affairs

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odds of building a lasting career here

57Sponsors, lottery-bound
Cap-exempt (no lottery)0
Sponsors this role76
Entry-level history0
PERM / green-card track0
Lottery odds (Level IV)94
Fits your clock70

Sponsors, but it's cap-subject — you still face the weighted lottery (~61% per draw at Level IV). Good if you win; have a cap-exempt backup on your list.

Lottery odds assume a STEM candidate.

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H-1B wage level

the lottery is wage-weighted — each level is one more entry

Level IV · 4×
Level I$73,5701 entry
Level II$97,7392 entries
Level III$121,8883 entries
Level IV$146,0584 entries

This range already reaches Level IV — the maximum four lottery entries.

DOL prevailing wage, 2026-27 wage year · Compliance Officers (13-1041) · San Francisco-Oakland-Fremont, CA. Wage level is derived by USCIS from the offered wage, occupation and worksite; the occupation shown is inferred from the job title.

Employer immigration record

from this employer's Department of Labor filings

Files H-1B transfers

1 transfer filing in the last year, covering 1 worker. Median labor-condition decision: 7 days. An employer that already files transfers is one that can take over an existing H-1B.

Sourced from Department of Labor LCA, PERM and prevailing-wage disclosure data. Employer matching is by name, so figures may be split across an employer's legal entities. Absence of a filing means none appears in our copy of the data, not that none exists.

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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.
  • 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.

Responsibilities

  • 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
  • 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
  • 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.

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
  • 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
  • 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
  • You work effectively with people of diverse backgrounds and job functions, including clinical, translational, computational, and life scientists
  • 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
  • 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

Nice to have

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

Compensation

  • 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.
  • 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.

Benefits

  • 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)
  • New hire stipend for home office setup
  • Monthly cell phone & internet stipend
  • Submissions & Health Authority Engagement
  • Influence Emerging Policy: Shape regulatory policy for artificial intelligence and machine learning through original publications, presentations, and stakeholder engagement
  • The application of AI and machine learning to diagnostics and drug development is accelerating, and regulatory science is catching up in real time.
  • 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

Company info

  • We believe diversity, equity, and inclusion need to be at the foundation of our culture.

Equal opportunity

  • insitro is an equal opportunity employer.
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This listing is sourced directly from Insitro's careers page and normalized into a canonical job model.