Hiring: Vice President, Regulatory Affairs Company: insitro Location: South San Francisco, CA Job Posted Time: 2026-09-10 10:27:05 Employment Type: Hybrid Target Skills & Keywords : AI, Assembly, Machine Learning About the job Experience: •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 Required Skills: •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 •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 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 •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 •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 •Computational Regulatory Experience: Exposure to regulatory approvals involving computationally-enabled tools or biomarkers, ideally including AI methods •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 Compensation: •$313,000 - $333,000 / year Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!