Vice President, Regulatory Affairs

What you'll do

• Develop global regulatory strategies and lead initial clinical-stage assets from IND/CTA through clinical proof-of-concept.
• Direct regulatory submissions and serve as primary interface with FDA and EMA, overseeing engagement with other health authorities and ethics committees.
• Build the regulatory function and team, and contribute to emerging AI/ML regulatory policy through publications, presentations, and stakeholder engagement.

What they ask for

• 10+ years in biotechnology and/or pharmaceutical regulatory affairs, including direct regulatory-lead and leadership experience.
• 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, 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.

Pay

$313,000 - $333,000 USD base salary

Tools

FDA, EMA, AI, machine learning, IND/CTA, NDA/BLA

AI focus

Shape AI/ML regulatory policy and develop data-driven regulatory approaches; interpret requirements for AI-related diagnostics and drug development.