Senior Vice President, Head of Global Regulatory Affairs
Core
Senior executive responsible for shaping and executing global regulatory strategy across the full drug development lifecycle, serving as a key advisor to senior leadership on regulatory risk and launch timing.
Role type
Senior Vice President, Head of Global Regulatory Affairs
Builds
Global regulatory strategy for late-stage development, product registration, and post-approval lifecycle management
Domain
Pharmaceutical/Biotechnology Regulatory Affairs
Deliverable
client delivery
Required skills
Global regulatory strategy, FDA/EMA/ICH compliance, CMC and clinical development oversight, post-approval lifecycle management, regulatory submission leadership, cross-functional team leadership, regulatory document review, external consultant management
Preferred skills
Advanced degree, experience in growing organizations, strategic judgment for market access and launch timing
Technologies
Electronic submission processes
Responsibilities
Develop and execute U.S. and global regulatory strategies; Provide regulatory direction and expert guidance to development teams and senior leadership; Lead global regulatory strategy across late-stage development, launch readiness, product registration, and post-approval lifecycle management; Oversee regulatory activities related to CMC, preclinical development, clinical development, commercialization, labeling, renewals, supplements, variations, and post-marketing commitments; Serve as the primary day-to-day liaison with regulatory authorities; Lead, develop, and scale the regulatory organization; Establish, maintain, and implement regulatory policies, standards, procedures, and operating practices; Ensure regulatory operations comply with applicable FDA, EU, ICH, EMA, and other relevant regulatory requirements and industry standards; Partner with Commercial, Medical Affairs, Legal and Compliance, Quality, Pharmacovigilance, Supply Chain, and Market Access teams; Oversee regulatory timelines, deliverables, and submission activities; Review, author, or edit regulatory and clinical documents; Identify and engage regulatory experts and external consultants; Support European regulatory and distribution requirements
Seniority
Senior Vice President, strategic leadership with hands-on oversight