Associate Director, Gene Therapy Regulatory Affairs

OCUGEN OPCO INC; Malvern (Chester County); On-site; USD 150,000 - 210,000; Full time

Job summary

OCUGEN OPCO INC is seeking an Associate Director, Regulatory Affairs – Gene Therapy, to shape regulatory strategy across development stages and engage global agencies to support accelerated pathways to approval.

You will partner with Clinical Development, Medical Affairs, and Regulatory teams to plan submissions and lifecycle management, ensuring timely delivery against program milestones in a dynamic biotech setting.

Qualifications

• 8+ years of experience in Regulatory Affairs in biotechnology or pharmaceuticals.
• Direct experience supporting clinical-stage programs, preferably gene therapy, biologics, or cell therapy.
• Experience participating in FDA/global health authority interactions.
• Hands-on experience supporting INDs, CTAs/IMPDs, BLA/MAA submissions, and lifecycle management.

Responsibilities

• Develop and execute global regulatory strategy for gene therapy programs from early 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, and agency responses.
• Collaborate with Clinical Development, Biometrics, Medical Writing, Safety, and Regulatory Operations to ensure timely milestones.
• Engage with FDA and global regulators, including meetings and submissions.
• Support regulatory strategy for expedited pathways (RMAT, Fast Track, Orphan Drug, PRIME).
• Contribute to scalable regulatory processes and cross-functional alignment within a fast-paced biotech environment.

Education

Bachelor’s or Master’s degree in life sciences

Advanced degree (MS, PhD, PharmD) preferred

Job description

OCUGEN OPCO INC is seeking an Associate Director, Regulatory Affairs – Gene Therapy, to shape regulatory strategy across development stages and engage global agencies to support accelerated pathways to approval.

You will partner with Clinical Development, Medical Affairs, and Regulatory teams to plan submissions and lifecycle management, ensuring timely delivery against program milestones in a dynamic biotech setting.