Associate Director of Regulatory Affairs

Job Summary

Associate Director of Regulatory Affairs is a full-time position responsible for supporting global regulatory strategy, overseeing processes, and managing regulatory risks for assigned programs while collaborating with cross-functional teams.

Key Responsibilities

• Build and manage regulatory strategies and activities across various jurisdictions
• Coordinate multiple projects and manage complex issues in a timely manner
• Create and implement regulatory procedures while supporting program leads in achieving business objectives

Required Qualifications

• Minimum of 10 years in the pharmaceutical industry, with at least 8 years in Global Regulatory Affairs
• Experience with major Health Authorities (e.g., US FDA, EMA, UK MHRA) is mandatory
• Minimum of 8 years experience with regulatory submissions such as INDs and NDAs
• Strong understanding of regulatory strategy and operational activities
• Experience working cross-functionally and on global teams