Vice President, Regulatory Affairs
insitroAI-driven Drug company
South San Francisco, United States$313,000 - $333,000Director
Andreessen Horowitz
BlackRock
CPP Investments
ARCH Venture Partners
Third Rock Ventures
Two Sigma Ventures
Leadership & General Management
About the role
TL;DR
Build and lead insitro's regulatory affairs function, shaping global strategies for novel therapeutics and diagnostics.
- •insitro is seeking a Vice President of Regulatory Affairs to build and lead its regulatory function from the ground up.
- •This founding role will develop and implement global regulatory strategies for therapeutics and diagnostics across multiple modalities and therapeutic areas.
- •Key Responsibilities Lead the entire regulatory function across three therapeutic areas and diverse modalities.
- •Design innovative regulatory strategies to enable data-driven decisions and shorten development cycles.
- •Serve as the primary interface with FDA and EMA, overseeing interactions with other global health authorities.
- •Shape regulatory policy for AI/ML through publications and stakeholder engagement.
- •Requirements 10+ years of experience in regulatory affairs in the biotechnology and/or pharmaceutical industries.
- •Experience taking therapeutics and diagnostic biomarkers from first-in-human through proof-of-concept to NDA/BLA submission.
- •Advanced degree in life sciences, technology, chemistry, or a related discipline.
- •Demonstrated command of regulations governing drug, diagnostic, and device development.
Required skills
PythonSQLAWSDockerKubernetesGitLinuxJiraConfluenceREST APIStrategic PlanningCross-functional Leadership
Domain expertise
biotechhealthtechai
Benefits & perks
Annual Performance Bonus Plan, Equity Incentive Plan, 401(k) plan with employer matching, Medical, dental, and vision coverage, Mental health and well-being support, Open, flexible vacation policy, Paid parental leave, 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, Access to a free commuter bus network
Tech stack
PythonSQLAWSDockerKubernetesGitLinuxJiraConfluenceREST API