Associate Director of Regulatory Affairs

Job Summary

A company is looking for an Associate Director, Regulatory Affairs.

Key Responsibilities

• Serve as a regulatory affairs lead on assigned clinical studies, developing global regulatory strategies
• Lead cross-functional teams in the preparation and maintenance of global regulatory submissions
• Manage interactions with global regulatory agencies and coordinate responses to information requests

Required Qualifications

• Bachelor's degree in biological, pharmaceutical, chemical, or related scientific discipline; advanced degree preferred
• At least 7 years of regulatory affairs experience within the biotechnology or pharmaceutical industry
• Demonstrated knowledge of FDA, EMA, and other global health authority regulations applicable to clinical development
• Hands-on experience with INDs, CTAs, and clinical regulatory submissions across multiple regions
• Prior experience in cell therapy or gene therapy is highly preferred