Global Regulatory Strategy Director

This position is listed on behalf of a partner company, which manages all applications and next steps. Our partner is looking for a Global Regulatory Strategy Director based in the United States.

As Global Regulatory Strategy Director, you will shape and lead regulatory strategies for an innovative pipeline of first-in-class small-molecule medicines. You will provide strategic regulatory leadership across clinical development, from Phase 2 through registration and lifecycle management. Acting as the regulatory subject matter expert, you will guide global project teams and lead interactions with health authorities worldwide. You will oversee the preparation and execution of critical regulatory submissions while identifying potential gaps and developing effective mitigation strategies. The role offers significant influence over global development and registration plans in a fast-moving, collaborative biotech environment. You will also lead and mentor regulatory colleagues while helping modernize regulatory operations and integrate AI into dossier development.