Global Regulatory Strategy Leader, Late-Stage Biotech

EPM Scientific; California (MO); On-site; USD 260,000 - 380,000; Full time

Job summary

EPM Scientific seeks a Vice President / Senior Vice President, Global Regulatory Affairs to lead global regulatory strategy across a multi-asset portfolio spanning oncology, neuroscience, immunology, and rare disease. This executive will own interactions with global health authorities and shape pathways for late-stage programs.

The role requires building scalable regulatory processes, guiding cross-functional teams, and ensuring readiness for pivotal trials while partnering with executives to

Qualifications

• 15+ years of regulatory experience in biopharmaceuticals with global strategy leadership.
• Hands-on experience driving regulatory strategy for late-stage drug development.
• Breadth across oncology, neuroscience, immunology, or rare disease; multi-asset exposure preferred.
• Successful track record with accelerated/expedited FDA/EMA programs and interactions.

Responsibilities

• Develop and execute global regulatory strategy from early development through registration and post-approval planning.
• Lead regulatory planning for accelerated approval, conditional pathways, and orphan/rare disease frameworks.
• Be the primary regulatory voice to executive leadership and Board-level stakeholders.
• Manage interactions with FDA, EMA, PMDA, and other authorities, including IND/CTA/NDA/BLA strategies.
• Oversee regulatory documentation and submissions for late-stage development and pivotal trials.
• Build and mentor a high-performing, globally distributed regulatory team.

Job description

EPM Scientific seeks a Vice President / Senior Vice President, Global Regulatory Affairs to lead global regulatory strategy across a multi-asset portfolio spanning oncology, neuroscience, immunology, and rare disease. This executive will own interactions with global health authorities and shape pathways for late-stage programs.

The role requires building scalable regulatory processes, guiding cross-functional teams, and ensuring readiness for pivotal trials while partnering with executives to