Senior Vice President Global Regulatory Affairs

A clinical‑stage biotechnology company pioneering next‑generation precision oncology therapeutics is seeking a Vice President/Senior Vice President Global Regulatory Affairs. Their approach is integrating cutting‑edge translational science, advanced patient‑selection methodologies, and a rapidly progressing clinical pipeline with the potential for accelerated global registration. This is a highly collaborative, science‑driven environment with teams across the U.S. and Europe and are now seeking a seasoned regulatory executive to lead our global regulatory vision as we transition toward late‑stage development.

The SVP, Global Regulatory Affairs will serve as the senior-most regulatory leader, responsible for shaping, executing, and scaling global regulatory strategy across a maturing oncology pipeline. This executive will oversee interactions with global health authorities, guide registration pathways for both therapeutics and associated enabling technologies, and build the infrastructure necessary for eventual commercialization.

This role is ideal for a hands‑on regulatory innovator who thrives in a fast‑moving clinical environment and is energized by working at the intersection of precision medicine, biomarkers, and accelerated regulatory pathways.

Responsibilities

• Develop and drive global regulatory strategy spanning early development through registration and post‑marketing planning.
• Lead regulatory planning for programs pursuing accelerated approval, conditional pathways, and innovative precision‑medicine frameworks.
• Serve as the primary regulatory voice to executive leadership and Board-level stakeholders.
• Lead all interactions with FDA, EMA, PMDA, and other regulatory agencies, including breakthrough/expedited programs, scientific advice meetings, and IND/CTA strategy.
• Oversee regulatory documentation and submissions for late‑stage development, including pivotal study planning and future marketing applications.
• Provide strategic direction for regulatory pathways involving patient‑selection tools, assays, or enabling technologies, including U.S. and OUS regulatory frameworks.
• Partner closely with translational sciences, clinical development, and external partners to align drug and diagnostic development when applicable.
• Collaborate deeply with Clinical, CMC, Biomarker, 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 oncology regulatory strategies.
• Successful track record with accelerated / expedited pathways, including FDA programs (Fast Track, Breakthrough, Priority Review) and EMA interactions.
• Experience leading or co‑leading regulatory strategy for programs involving novel biomarkers, diagnostics, or patient‑selection tools (without specifying proteomics or CDx).
• Prior responsibility for regulatory strategy from Phase 2 through registration.
• Exceptional communication skills, scientific fluency, and ability to translate complex data into regulatory strategy.