AD/ Director, Clinical Regulatory Affairs Gene Therapy

Responsibilities:
- Support development and execution of global regulatory strategy for gene therapy programs from early clinical development through potential registration.
- Provide regulatory guidance on clinical development plans, study design, endpoints, protocol development, and lifecycle planning.
- Lead or support preparation of regulatory submissions, including INDs, CTA/IMPDs, BLAs/MAAs, briefing packages, responses to agency questions, and other health authority communications.
- Partner with Clinical Development, Clinical Operations, Biometrics, Medical Writing, Safety, and Regulatory Operations to align regulatory milestones.
- Support and participate in FDA and global agency interactions (Type A/B/C meetings, INTERACT, scientific advice, pre-BLA).
- Develop regulatory strategy for expedited/innovative pathways (RMAT, Fast Track, Orphan Drug, PRIME, and related designations).
- Collaborate with technical and quality functions to ensure complete, aligned submissions delivered on timeline.
- Support integrated regulatory planning across clinical, nonclinical, and product development.

Qualifications:
- Bachelor’s or Master’s degree in life sciences required; MS/PhD/PharmD preferred.
- 8+ years’ Regulatory Affairs experience in biotechnology/pharmaceuticals with direct experience in gene therapy, cell therapy, or biologics.
- Direct experience supporting clinical-stage biotechnology programs (preferably gene therapy/biologics/cell therapy/advanced therapeutics).
- Experience participating in FDA and/or global health authority interactions.
- Hands-on experience with INDs, CTAs/IMPDs, BLA/MAA submissions, and lifecycle management.
- Strong understanding of expedited pathways and evolving regulatory frameworks for advanced therapies.
- Experience in fast-paced, highly collaborative biotech environments with cross-functional visibility.