VP​/SVP regulatory Affairs

I am working with an exciting Precision Oncology biopharma, who are on the lookout for a Regulatory Affairs Executive to advance it's high potential, clinical stage pipeline.

This is a highly visible leadership role, owning the global Regulatory Affairs function, sitting on the Development Leadership Team, and playing a key role in shaping regulatory strategy for a differentiated biomarker-driven oncology pipeline.

• Define and execute the global regulatory strategy across multiple oncology programs from early development through registration
• Lead strategic interactions with FDA, EMA, MHRA, PMDA and other global health authorities
• Drive regulatory plans for key milestones including IND/CTA activities, end-of-Phase discussions, expedited pathways and pivotal studies
• Provide regulatory leadership across precision medicine, biomarker strategy and companion diagnostic initiatives
• Influence clinical development strategy through close partnership with Clinical Development, Translational Medicine, Biomarker Sciences, CMC, Quality and Medical teams
• Oversee regulatory submissions, briefing documents and agency engagement strategies
• Build and scale a high-performing Regulatory Affairs function as the company advances its pipeline
• Serve as a trusted regulatory advisor to executive leadership and support portfolio-level decision making

The role is hybrid, with an expectation of being onsite in MA 3–4 days per week, with a highly competitive financial package available.

Please note, candidates require precision oncology experience, with 15+ years experience working across regulatory strategy, from Pre-IND through BLA/NDA filing.