Director of Regulatory Affairs

Job Summary

A company is looking for a Director of Regulatory Affairs to provide strategic leadership in global regulatory activities for gene therapy programs.

Key Responsibilities

• Define and lead global regulatory strategies for gene therapy programs
• Oversee complex regulatory submissions including INDs and CTAs
• Act as the primary regulatory lead for interactions with FDA, EMA, and other global health authorities

Required Qualifications

• PhD, PharmD, MD, or MS in a life sciences-related discipline
• 10-15+ years of regulatory affairs experience with leadership in development programs
• Proven experience in leading global regulatory submissions and agency meeting strategy
• Deep understanding of regulatory pathways for biologics and gene therapy products
• Strong leadership and decision-making skills in biotech settings