Senior Manager Regulatory Affairs

Job Summary

A company is looking for a Senior Manager / Associate Director, Regulatory Affairs.

Key Responsibilities:

• Contribute to and shape global regulatory strategies for product development and registration
• Lead preparation and review of regulatory submissions including INDs, CTAs, and orphan drug applications
• Support regulatory interactions with health authorities and ensure consistent communication

Required Qualifications:

• Experience in rare disease drug development and combination products
• Proven track record of advancing programs through late-phase clinical development
• Strong knowledge of global regulatory requirements and compliance
• Ability to work collaboratively across cross-functional teams
• Experience in regulatory submissions and health authority interactions