Vice President, Regulatory Affairs

The role

You will build and lead the regulatory function from the ground up. You will develop global regulatory strategies for therapeutics and diagnostics across neurology, metabolism, and ophthalmology.

What you will do

• Own the entire regulatory function across three therapeutic areas and diverse modalities
• Build regulatory approaches for data-driven decisions
• Lead regulatory strategy for initial clinical-stage assets
• Hire and manage a team of global regulatory leads
• Be accountable for global regulatory strategy from IND/CTA through clinical proof-of-concept
• Direct the creation, review, assembly, and submission of clinical, CMC, device, and nonclinical functions
• Serve as the primary interface with FDA and EMA
• Oversee interactions with other global health authorities and ethics committees
• Identify and address regulatory risks
• Shape regulatory policy for artificial intelligence and machine learning

Required qualifications

• 10+ years of experience in regulatory affairs in biotechnology and/or pharmaceutical industries
• Experience as a regulatory lead and 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
• Specialized degree in regulatory science (e.g., M.S.) or equivalent practical experience
• Command of regulations and guidelines governing drug, diagnostic, and device development
• Knowledge of good clinical practice, clinical trial design and execution, clinical pharmacology, biostatistics, and clinical operations

Nice to have

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

Benefits

• 401(k) plan with employer matching
• Medical, dental, and vision coverage
• Mental health and well-being support
• Open, flexible vacation policy
• Paid parental leave of at least 16 weeks for birth parents and 10 weeks for new parents
• Quarterly budget for books and online courses
• New hire stipend for home office setup
• Monthly cell phone & internet stipend
• Access to free onsite baristas and daily lunch for onsite or hybrid employees
• Access to a free commuter bus network

About the company

insitro is a drug discovery and development company using machine learning and data at scale to decode biology for transformative medicines. The company uses a Virtual Human platform and TherML platform to identify genetic intervention points and translate them into therapeutics.