Regulatory Affairs Director

Job Summary

A company is looking for an Associate Director/Director of Regulatory Affairs.

Key Responsibilities

• Develop and execute early-phase regulatory strategies for gene therapy programs
• Translate nonclinical study designs and toxicology results into regulatory narratives
• Author and lead regulatory documents and prepare for FDA interactions

Required Qualifications

• Master's degree or higher in a life sciences discipline; PhD strongly preferred
• Direct hands-on regulatory experience in gene therapy
• Demonstrated involvement in Pre-IND activities and early IND-enabling work
• Proven ability to produce high-quality regulatory writing for agency review
• Experience collaborating with nonclinical and clinical teams in early-stage development