Vice President, Regulatory Affairs
insitro· Clinical Development
South San Francisco, CA$313k - $333kFull-timePosted 2mo ago
About the role
Regulatory leadership role at insitro to build and lead the global regulatory function across multiple modalities and therapeutic areas, reporting to the Chief Medical Officer. Focus on regulatory strategy, submissions, health authority engagements, and shaping AI/ML regulatory policy as the first dedicated regulatory leader.
Responsibilities
- Lead the Regulatory function across three therapeutic areas, diverse modalities, and novel biomarker technologies
- Design innovative, data-driven regulatory strategies to shorten development timelines
- Personally lead regulatory strategy for initial clinical-stage assets and subsequently build and manage a global regulatory team
- Own end-to-end regulatory strategy from IND/CTA through proof-of-concept across diverse pathways
- Direct creation, review, assembly, and submission of regulatory sections across clinical, CMC, device, and nonclinical functions
- Serve as primary interface with FDA and EMA; oversee interactions with other regulatory authorities and ethics committees
- Mitigate regulatory risk to prevent development delays
- Influence policy development for AI/ML regulatory landscape through publications, presentations, and stakeholder engagement
- Translate regulatory requirements for project teams, executive leadership, board, and scientific advisory board
Qualifications
- 10+ years in regulatory affairs in biotechnology/pharmaceutical industries, including leadership roles
- Experience taking therapeutics and diagnostic biomarkers from first-in-human to NDA/BLA in metabolic disease, neurology/neurodegeneration, or oncology
- Advanced degree in life sciences/technology/chemistry with specialized regulatory science credential or equivalent experience
- Strong command of regulations for drug, diagnostic, and device development, including GCP, trial design, pharmacology, biostatistics, and operations
Skills
Required:Regulatory strategyHealth authority engagementRegulatory submissionsLeadership & building teams
Benefits
- Annual Performance Bonus Plan participation
- Equity Incentive Plan
- 401(k) with employer matching
- Medical, dental, and vision coverage including mental health support
- Open, flexible vacation policy
- Paid parental leave (16 weeks for birth; 10 weeks for new parent)
- Quarterly budget for books and online courses
- New hire home office stipend
- Monthly cell phone & internet stipend
- Free onsite daily lunch and beverages for onsite/hybrid employees
- Free commuter bus network to SSF HQ
Last updated Oct 22, 2026. Interested? Apply on the company site.
About insitro
Making Medicines Differently
At insitro, we are building a different kind of drug company to bring better drugs faster to the patients who can benefit most. Through the power of machine learning (ML) and data at scale, we decode the complexities of biology to unlock transformative new medicines.
PipelinePlatformPeoplePublications & PressML-driven platformdrug discoveryneurosciencemetabolism
More open roles at insitro
- Director, Financial Reporting & Technical Accounting4d agoHybrid (South San Francisco, CA) · General & Administrative
- Vice President, FP&A & Financial Transformation4d agoSouth San Francisco, CA · General & Administrative
- Senior Manager / Director, Statistical Genetics4w agoSouth San Francisco, CA · Data Science and Machine Learning
- Full Stack Software Engineer, Lab Platform (LIMS)4w agoSouth San Francisco, CA · Software Engineering
- Associate Scientist III, Cardiac Modeling1mo agoSouth San Francisco, CA · Therapeutic Areas