Vice President Regulatory Affairs (Boston)
VP, Regulatory Affairs (Clinical-Stage Biotech – Neuro / I&I)
Overview
Clinical-stage biotech is seeking a VP, Regulatory Affairs to lead regulatory strategy and execution across a growing clinical pipeline
Key Responsibilities
- Lead regulatory strategy and execution from IND through Phase I/II/III
- Oversee IND/CTA submissions and ongoing regulatory filings
- Lead interactions with global health authorities (FDA)
- Partner cross-functionally with Clinical, CMC, and Medical teams
- Provide regulatory guidance for novel delivery approaches, including device-related programs
Requirements
- 12+ years regulatory experience in biotech/pharma
- Strong IND–Phase III experience in clinical-stage development
- Background in neurology or immunology preferred
- Prior leadership in small/mid-sized biotech strongly preferred
- Hands-on, execution-focused mindset
Additional
- Fast-growing biotech with multiple clinical programs
- Collaborative, agile team environment
- Flexible Boston/remote structure
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