Vice President Regulatory Affairs Job at Barrington James, Boston, MA

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  • Barrington James
  • Boston, MA

Job Description

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

Job Tags

Remote work, Flexible hours

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