Global Regulatory Strategy Director

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.

• Bachelor's degree in a scientific discipline; an advanced degree such as an MS, PharmD, or PhD is preferred.

• At least 12 years of Regulatory Affairs experience within the pharmaceutical or biotechnology industry.

• Broad regulatory experience across multiple stages of drug development, ideally spanning the full development lifecycle.

• Proven ability to develop and execute global regulatory strategies for clinical-stage and commercial-stage programs.

• Strong experience with oral small-molecule drug development and regulatory submissions ranging from IND/CTx applications through NDA or other marketing authorization applications.

• Demonstrated experience negotiating and interacting with major global health authorities, particularly the FDA, EMA, and Health Canada.

• Experience in obesity or dermatology programs is strongly preferred.

• Excellent written, verbal, and presentation skills, including the ability to communicate complex regulatory matters and present strategic recommendations to senior leadership.

• Strong cross-functional collaboration skills and the ability to represent Regulatory Affairs effectively within global project teams.

• Solid understanding of regulatory operations, submission processes, and health authority reporting requirements.

• Excellent organizational and planning capabilities, with the ability to manage multiple complex projects and competing deadlines in a fast-paced environment.

• A proactive, independent, and entrepreneurial approach, with the flexibility to adapt to evolving priorities and business needs.

• A pragmatic, solution-oriented mindset grounded in regulatory compliance and sound judgment.