Vice President, Regulatory Affairs
Core
Build and lead the global regulatory function for a physical AI drug discovery company, supporting novel therapeutics (small molecules, biologics, oligos) and diagnostics in neurology, metabolism, and ophthalmology.
Role type
VP of Regulatory Affairs (Founding/Zero-to-One)
Builds
Global regulatory strategy, IND/CTA/NDA/BLA submissions, and a dedicated regulatory team for clinical-stage assets.
Domain
Biotechnology / Pharmaceutical / Regulatory Science / AI in Drug Development
Deliverable
client delivery
Required skills
Global regulatory strategy, IND/CTA/NDA/BLA submission management, health authority engagement (FDA/EMA), clinical trial design and execution, clinical pharmacology, biostatistics, clinical operations, regulatory risk mitigation, team building, SOP creation.
Preferred skills
Computational regulatory experience, AI/ML regulatory approvals, experience with digital biomarkers.
Technologies
None explicitly listed as tools/frameworks.
Responsibilities
Lead the entire regulatory function across diverse modalities and therapeutic areas; Design innovative data-driven regulatory strategies; Serve as primary interface with FDA, EMA, and ethics committees; Drive end-to-end submission creation and review; Influence emerging AI/ML regulatory policy through publications and stakeholder engagement.
Seniority
VP, Founding/Zero-to-One Builder