Vice President, Regulatory Affairs

Insitro
United States
Workplace: HybridFull timeUSD 313,000 - 333,000 annuallyFunction: Quality & Regulatory (Non-Software)Experience: 10+ yearsEducation: mastersSkills: ["Leadership","Cross-functional collaboration","Stakeholder management","Risk mitigation","Strategic thinking"]

Build insitro’s regulatory function from the ground up as its first dedicated regulatory leader. Own global regulatory strategy across multiple therapeutic areas and modalities—from IND/CTA through proof-of-concept—while personally leading strategy for initial clinical-stage assets. Serve as primary interface with FDA and EMA and oversee submission planning for INDs, CTAs, NDAs, BLAs, and MAAs. Influence emerging AI/ML regulatory policy and translate requirements for leadership.

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Insitro
Insitro
1 day ago

Vice President, Regulatory Affairs

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Job Summary

Build insitro’s regulatory function from the ground up as its first dedicated regulatory leader. Own global regulatory strategy across multiple therapeutic areas and modalities—from IND/CTA through proof-of-concept—while personally leading strategy for initial clinical-stage assets. Serve as primary interface with FDA and EMA and oversee submission planning for INDs, CTAs, NDAs, BLAs, and MAAs. Influence emerging AI/ML regulatory policy and translate requirements for leadership.
Location: United States
Workplace: Hybrid
Employment Type: Full time
Job Function: Quality & Regulatory (Non-Software)
Seniority: Sr. Director level

Key Responsibilities

  • •Own and lead the entire regulatory function across three therapeutic areas and diverse modalities, including in-licensed and internally developed assets.
  • •Build data-driven regulatory approaches to enable objective go/no-go decisions and shorten development cycles across an evolving regulatory landscape.
  • •Lead global regulatory strategy end-to-end from IND/CTA through clinical proof-of-concept and then build and manage a team of global regulatory leads as the pipeline grows.
  • •Direct the creation, review, assembly, and submission of INDs, CTAs, NDAs, BLAs, and MAAs across clinical, CMC, device, and nonclinical functions.
  • •Serve as primary interface with FDA and EMA, oversee interactions with other health authorities and ethics committees, and proactively identify and mitigate regulatory risks.

Pay and Benefits

Salary: USD 313,000 - 333,000 annually
Equity and Bonus:Equity
Perks:401kHealth InsuranceDentalVisionPaid LeaveParental LeaveLearning BudgetHome OfficeMeal AllowanceInternet StipendPhone Stipend

Key Requirements

  • •10+ years of regulatory affairs experience in biotechnology and/or pharmaceutical industries, including time as a regulatory lead in a leadership role.
  • •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.
  • •Demonstrated command of regulations and guidelines for drug, diagnostic, and device development, including good clinical practice and clinical trial design/execution.
  • •Exposure to regulatory approvals involving computationally-enabled tools or biomarkers, ideally including AI methods.
Experience:10+ yearsBiotechnologyPharmaceuticals
Education:Master's in life sciences, technology, chemistry, or a related discipline (regulatory science)
Skills:LeadershipCross-functional collaborationStakeholder managementRisk mitigationStrategic thinking

Company Brief

Insitro
Insitro is a machine-learning-driven drug discovery and development company that integrates high-throughput biology, human genetics, and AI to identify therapeutic targets and design medicines across metabolic and neurodegenerative diseases.
Industry: Biotech
Company Size: Large (251 to 1,000 employees)
Growth: Scaleup
Funding: Series C
Headquarters: South San Francisco, United States
Founded: 2018
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