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.