Director, Gene Therapy Regulatory Strategy

BioSpace; Malvern (Chester County); On-site; USD 180,000 - 230,000; Full time

Job summary

Ocugen is seeking an Associate Director of Regulatory Affairs – Gene Therapy to drive regulatory strategy and global submissions for clinical-stage programs. You will partner with executive leadership and functional teams to support accelerated pathways toward potential approval and commercialization.

The role requires 8+ years in regulatory affairs within biotech/pharma, with direct gene therapy or biologics experience.

Qualifications

• Bachelor’s or Master’s in life sciences required.
• 8+ years of Regulatory Affairs experience in biotech/pharma.
• Direct experience with gene therapy, cell therapy, or biologics.
• Experience participating in FDA and/or global health authority interactions.

Responsibilities

• Develop and execute global regulatory strategy for gene therapy programs from early development through potential registration.
• Provide strategic regulatory guidance on study designs, endpoints, and lifecycle planning.
• Lead or support regulatory submissions (INDs, CTAs/IMPDs, BLAs/MAAs) and agency communications.
• Collaborate with Clinical Development, Biometrics, Medical Writing, Safety, and Regulatory Operations to meet milestones.
• Engage with FDA and global health authorities in meetings (Type A/B/C, INTERACT, scientific advice).
• Support expedited pathways (RMAT, Fast Track, Orphan Drug, PRIME) and evolving guidance for advanced therapies.
• Ensure submissions are complete, aligned, and delivered on program timelines.
• Support integrated regulatory planning across clinical, nonclinical, and product development.

Skills

Regulatory strategy

FDA interactions

Cross-functional collaboration

IND/CTA submissions

Global regulatory planning

Education

Bachelor’s or Master’s in life sciences

Advanced degree preferred (MS/PhD/PharmD)

Job description

Ocugen is seeking an Associate Director of Regulatory Affairs – Gene Therapy to drive regulatory strategy and global submissions for clinical-stage programs. You will partner with executive leadership and functional teams to support accelerated pathways toward potential approval and commercialization.

The role requires 8+ years in regulatory affairs within biotech/pharma, with direct gene therapy or biologics experience.