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. The opportunity offers the chance to: 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. #J-18808-Ljbffr Verto People