Associate Director of Regulatory Affairs

Job Summary

A company is looking for an Associate Director of Regulatory Affairs to support regulatory strategy and global filings for gene therapy development in a remote contract position.

Key Responsibilities

• Support the development and execution of global regulatory strategies from preclinical through early clinical stages
• Lead preparation and maintenance of regulatory submissions including INDs, CTAs, and related amendments
• Partner cross-functionally with clinical, nonclinical, quality, and CMC teams to ensure regulatory alignment

Required Qualifications

• PhD, PharmD, MD, or MS in life sciences, molecular biology, pharmacology, or a related discipline
• 7-10 years of regulatory affairs experience within biotechnology or pharmaceutical development
• Hands-on experience supporting INDs, CTAs, and early-phase clinical programs
• Working knowledge of biologics and gene therapy regulatory pathways, including nonclinical requirements
• Strong regulatory writing skills with the ability to communicate effectively across functions