AD/ Director, Clinical Regulatory Affairs Gene Therapy
About The Position
The Associate Director, Regulatory Affairs – Gene Therapy will play a highly visible role in advancing Ocugen’s clinical-stage gene therapy programs through critical phases of development and global regulatory engagement. This individual will help shape regulatory strategy for innovative therapies intended to address serious unmet medical needs and will work closely with executive leadership, Clinical Development, Clinical Operations, Medical Affairs, and Regulatory teams to support accelerated pathways toward potential approval and commercialization. This is a unique opportunity to contribute meaningfully to multiple gene therapy programs at a pivotal stage of growth, with direct exposure to FDA and global health authority interactions, cross-functional development strategy, and late-stage regulatory planning. The ideal candidate brings strong clinical regulatory experience within biotechnology or pharmaceuticals, preferably in gene therapy, biologics, or other advanced therapeutics.
Requirements
- Bachelor’s or Master’s degree in life sciences required; advanced degree (MS, PhD, PharmD) preferred.
- 8+ years of experience in Regulatory Affairs within biotechnology or pharmaceuticals, with direct experience in gene therapy, cell therapy, or biologics.
- Direct experience supporting clinical-stage biotechnology programs, preferably within gene therapy, biologics, cell therapy, or advanced therapeutics.
- Experience participating in FDA and/or global health authority interactions.
- Hands-on experience supporting INDs, CTAs/IMPDs, BLA/MAA submissions, and lifecycle management activities.
- Strong understanding of expedited regulatory pathways and evolving regulatory frameworks for advanced therapies.
- Experience working in fast-paced, highly collaborative biotech environments with significant cross-functional visibility.
Responsibilities
- Support development and execution of global regulatory strategy for Ocugen’s gene therapy programs from early clinical development through potential registration.
- Provide strategic 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 closely with Clinical Development, Clinical Operations, Biometrics, Medical Writing, Safety, and Regulatory Operations to ensure aligned execution of regulatory milestones.
- Support and participate in interactions with FDA and global regulatory agencies including Type A/B/C meetings, INTERACT meetings, scientific advice meetings, and pre-BLA discussions.
- Contribute to regulatory strategy for expedited and innovative approval pathways including RMAT, Fast Track, Orphan Drug, PRIME, and related designations.
- Collaborate with technical and quality functions to ensure regulatory submissions are complete, aligned, and delivered according to program timelines.
- Support integrated regulatory planning across clinical, nonclinical, and product development activities.
- Serve as a key regulatory representative on cross-functional program teams supporting clinical advancement and corporate objectives.
- Help identify regulatory risks, develop mitigation strategies, and support proactive agency engagement plans.
- Contribute to regulatory intelligence activities and interpretation of evolving global guidance related to gene therapy and advanced biologics.
- Support development of scalable regulatory processes, tools, and best practices within a fast-paced biotechnology environment.
- Collaborate closely with senior leadership on program priorities, timelines, and strategic development opportunities.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
