Senior Manager – Regulatory Affairs

Role Overview

• Support development and execution of global regulatory strategy
• Oversee global regulatory submissions and health authority interactions
• Lead regulatory activities for assigned development programs
• Collaborate with cross-functional teams to integrate regulatory considerations

Requirements

• Experience in regulatory affairs for drug-device combination products
• Experience with rare disease drug development
• Proven track record in late-phase clinical development
• Experience in global regulatory submissions
• Strong understanding of regulatory strategy and compliance