VP Regulatory

Vice President / Senior Vice President, Global Regulatory Affairs
A clinical-stage biotechnology company with a broad, multi-asset portfolio spanning oncology, neuroscience, immunology, and rare disease is seeking a Vice President/Senior Vice President, Global Regulatory Affairs. The organization pairs strong translational science with a diversified pipeline advancing across multiple therapeutic areas, several with potential for expedited global registration. This is a collaborative, science-led environment with teams across the U.S. and Europe, now looking for a seasoned regulatory executive to lead the global regulatory vision as the portfolio transitions toward late-stage development.
The VP/SVP, Global Regulatory Affairs will serve as the senior-most regulatory leader, responsible for shaping, executing, and scaling global regulatory strategy across a maturing multi-therapeutic-area pipeline. This executive will own interactions with global health authorities, guide registration pathways across a range of modalities and indications, and build the infrastructure required to support eventual commercialization.
This role suits a hands-on regulatory leader who thrives in a fast-moving clinical environment and is energized by the breadth of working across several therapeutic areas at once.
Responsibilities
Develop and drive global regulatory strategy from early development through registration and post-marketing planning across the full portfolio.
Lead regulatory planning for programs pursuing accelerated approval, conditional pathways, and orphan/rare disease frameworks.
Serve as the primary regulatory voice to executive leadership and Board-level stakeholders.
Lead all interactions with FDA, EMA, PMDA, and other health authorities, including expedited programs, scientific advice meetings, and IND/CTA/NDA/BLA strategy.
Oversee regulatory documentation and submissions for late-stage development, including pivotal study planning and future marketing applications.
Prioritize and sequence regulatory resourcing across competing programs in oncology, neuroscience, immunology, and rare disease.
Partner closely with translational sciences, clinical development, and external partners to align strategy across assets.
Collaborate deeply with Clinical, CMC, Program Management, and Commercial Planning.
Build, scale, and mentor a high-performing global regulatory team.
Establish regulatory systems, processes, and documentation standards aligned with late-stage expectations.
Ensure inspection readiness and compliance as the organization moves toward pivotal trials.
Qualifications
15+ years of regulatory experience within the biopharmaceutical industry, including leadership of global regulatory strategy.
Hands-on experience driving regulatory strategy for late-stage drug development is a requirement.
Demonstrated breadth across multiple therapeutic areas; direct experience in two or more of oncology, neuroscience, immunology, or rare disease strongly preferred.
Successful track record with accelerated/expedited pathways, including FDA programs (Fast Track, Breakthrough, Priority Review, Orphan Drug) and EMA interactions.
Prior responsibility for regulatory strategy from Phase 2 through registration.
Comfortable operating in a fast-paced, resource-conscious environment.
Experience across both small molecule and biologics is a plus.
Exceptional communication skills, scientific fluency, and the ability to translate complex data into regulatory strategy.

Work arrangement
Yes