AD/ Director, Clinical Regulatory Affairs Gene Therapy

Ocugen; Malvern (Chester County); On-site; USD 180,000 - 240,000; Full time

Job summary

Ocugen seeks an Associate Director, Regulatory Affairs – Gene Therapy to drive global regulatory strategy for clinical-stage programs and manage interactions with FDA and health authorities. You will shape development plans, submissions, and lifecycle management in a fast-paced biotech environment.

The role requires strong regulatory experience in gene therapy or biologics, with an emphasis on expedited pathways and cross-functional collaboration to accelerate potential approvals.

Qualifications

• 8+ years of Regulatory Affairs experience in biotechnology or pharmaceuticals, with direct gene therapy/biologics exposure.
• Hands-on experience supporting INDs, CTAs/IMPDs, BLA/MAA submissions, and lifecycle management.
• Experience interacting with FDA and other global health authorities.
• Strong understanding of expedited regulatory pathways for advanced therapies.

Responsibilities

• Develop and execute global regulatory strategy for gene therapy programs from early development through potential registration.
• Provide strategic regulatory guidance on study design, endpoints, protocol development, and lifecycle planning.
• Lead or support regulatory submissions and health authority communications across multiple programs.
• Collaborate with Clinical Development, Operations, Biometrics, Medical Writing, Safety, and Regulatory Operations to align milestones.
• Engage with FDA and global agencies in meetings and discussions, including RMAT/FAST TRACK/Orphan designations.

Skills

Regulatory strategy

Cross-functional collaboration

Regulatory submissions

FDA interactions

Lifecycle management

Education

Bachelors or Masters in life sciences

Advanced degree (MS, PhD, PharmD) preferred

Job description

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.

Responsibilities

Clinical Regulatory Strategy & Execution

• 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.

Regulatory Leadership & Cross-Functional Collaboration

• 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.

Qualifications

• 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.

Working Conditions

This position operates in an office setting, in person. Job may additionally require incumbent to be available outside of these hours to handle priority business needs.

Ocugen is an equal opportunity employer. In order to provide equal employment and advancement opportunities to all individuals, we make all of our employment decisions based upon merit, qualifications, abilities, and an individual’s conduct and performance. We will not make any of our decisions, and will not discriminate against any employee or applicant, on the basis of race, color, religion, creed, national origin or ancestry, ethnicity, sex (including pregnancy), gender (including sexual orientation, gender identity and status as a transgender or transsexual individual), age, physical or mental disability, citizenship, past, current or prospective service in the uniformed services, genetic information, or any other characteristic protected from discrimination under the law. Ocugen complies with applicable federal, state and local laws governing nondiscrimination in employment.