Regulatory Strategy Lead - Gene Therapy

BioSpace; Malvern (Chester County); On-site; USD 180,000 - 260,000; Full time

Job summary

Ocugen is seeking an Associate Director, Regulatory Affairs - Gene Therapy to lead regulatory strategy for clinical‑stage gene therapy programs and drive global regulatory engagement. You will partner with Clinical Development, Medical Affairs, and Regulatory teams to support accelerated pathways toward potential approval and commercialization.

The role requires 8+ years in Regulatory Affairs with gene/cell therapy experience and a track record with FDA interactions, IND/CTA submissions, and

Qualifications

• Bachelor’s or Master’s in life sciences required; advanced degree preferred.
• 8+ years in Regulatory Affairs in biotech/pharma, with gene/cell therapy or biologics.
• Experience with FDA/global health authority interactions.
• Hands-on experience supporting INDs, CTAs/IMPDs, BLA/MAA submissions.

Responsibilities

• Develop and execute global regulatory strategy from early development through potential registration.
• Provide guidance on clinical development plans, study design, endpoints, and lifecycle planning.
• Lead preparation of regulatory submissions and agency communications.
• Collaborate with cross-functional teams to ensure timely milestones.
• Support interactions with FDA and global agencies including meetings.
• Contribute to expedited pathways designations.
• Ensure regulatory submissions are complete and aligned with timelines.
• Support integrated regulatory planning across activities.

Skills

Regulatory strategy

Cross-functional leadership

FDA/regulatory agency interactions

IND/CTA/IMPD submissions

Education

Bachelor's or Master's in life sciences

MS/PhD/PharmD preferred

Job description

Ocugen is seeking an Associate Director, Regulatory Affairs - Gene Therapy to lead regulatory strategy for clinical‑stage gene therapy programs and drive global regulatory engagement. You will partner with Clinical Development, Medical Affairs, and Regulatory teams to support accelerated pathways toward potential approval and commercialization.

The role requires 8+ years in Regulatory Affairs with gene/cell therapy experience and a track record with FDA interactions, IND/CTA submissions, and