Vice President Regulatory Affairs
Barrington James, Boston, MA, United States
Overview
Clinical-stage biotech is seeking a VP, Regulatory Affairs to lead regulatory strategy and execution across a growing clinical pipeline
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
Qualifications
12+ years regulatory experience in biotech/pharma
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
#J-18808-Ljbffr
Clinical-stage biotech is seeking a VP, Regulatory Affairs to lead regulatory strategy and execution across a growing clinical pipeline
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
Qualifications
12+ years regulatory experience in biotech/pharma
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
#J-18808-Ljbffr