Regulatory Strategy Director, Renal

Job title: Regulatory Strategy Director, Renal

About the Role The Regulatory Affairs Director will provide global regulatory leadership for programs within the Renal Therapy Team. This role is responsible for defining and driving regulatory strategy for the International region that is aligned with global strategies to support timely advancement of investigational assets. The Director will serve as the regulatory lead on cross-functional teams and will partner closely with Clinical Development, Nonclinical, CMC, Safety, Medical Affairs, Commercial, and Program Leadership to help shape development plans and support business objectives. This individual will bring strong strategic regulatory expertise, sound judgment, and the ability to navigate complex global regulatory environments. The role requires a collaborative leader who can influence across functions, represent Regulatory Affairs in key governance forums, and lead interactions with health authorities.

What You'll Do

• Lead the development and execution of global regulatory strategies for renal therapy programs across all phases of development
• Serve as the regulatory representative on cross-functional program teams, providing strategic input to development plans, evidence generation, and milestone planning
• Drive regulatory strategy and lead interactions with health authorities

What We're Looking For

• Strong strategic regulatory expertise, sound judgment, and ability to navigate complex global regulatory environments
• Experience providing regulatory leadership for renal therapy programs across development phases
• Collaborative leader who can influence across functions and represent Regulatory Affairs in governance forums
• Ability to lead interactions with health authorities and regulatory agencies