Associate Director, Clinical Regulatory Affairs (Gene Therapy)

Location: In-person office setting in Malvern, Pennsylvania, United States

Company

hirify.global develops clinical-stage gene therapy programs for serious unmet medical needs.

What you will do

• Support global regulatory strategy and execution for gene therapy programs from early clinical development through potential registration.
• Provide regulatory guidance on clinical development plans, study designs, endpoints, protocols, and lifecycle planning.
• Lead or support preparation of INDs, CTAs/IMPDs, BLAs/MAAs, briefing packages, agency responses, and other health authority communications.
• Participate in interactions with the FDA and global regulatory agencies, including Type A/B/C, INTERACT, scientific advice, and pre-BLA meetings.
• Develop regulatory strategies for RMAT, Fast Track, Orphan Drug, PRIME, and other expedited approval pathways.
• Represent Regulatory Affairs on cross-functional teams, identify regulatory risks, and support mitigation and agency engagement plans.

Requirements

• Bachelor’s or Master’s degree in life sciences required; an MS, PhD, or PharmD is preferred.
• 8+ years of Regulatory Affairs experience in biotechnology or pharmaceuticals, including direct experience with gene therapy, cell therapy, or biologics.
• Experience supporting clinical-stage biotechnology programs and participating in FDA or global health authority interactions.
• Hands-on experience with IND, CTA/IMPD, BLA/MAA submissions and lifecycle management.
• Strong understanding of expedited regulatory pathways and regulatory frameworks for advanced therapies.
• Experience working in fast-paced, highly collaborative biotechnology environments.

Culture & Benefits

• Work in a fast-paced biotechnology environment with significant cross-functional visibility.
• Collaborate with Clinical Development, Clinical Operations, Biometrics, Medical Writing, Safety, Regulatory Operations, Quality, and senior leadership.
• Availability outside regular working hours may be required for priority business needs.