Senior Manager, Regulatory Affairs - Clinical

Purpose

The Senior Manager, Regulatory Affairs – Clinical will serve as the regulatory lead for assigned clinical programs within Ocugen’s gene therapy portfolio, including modifier gene therapies for inherited and degenerative retinal diseases.

This role develops and executes clinical regulatory strategy, owns clinical trial applications through their lifecycle, leads preparation for health authority interactions, and partners closely with Clinical Development, Clinical Operations, Safety, and Medical Writing to advance programs from clinical development through registration. This is an onsite role.

Responsibilities

Clinical Regulatory Strategy

• Develop and execute clinical regulatory strategy for assigned gene therapy programs, aligned with global development plans and Ocugen’s corporate objectives.
• Serve as the regulatory lead on cross-functional program and study teams, providing guidance on regulatory requirements, risks, and timelines.
• Provide regulatory input on clinical development plans, study designs, endpoints, and patient populations, including pivotal and late-stage studies.
• Lead preparation of expedited program and designation requests (e.g., Orphan Drug, Fast Track, RMAT, PRIME, ATMP classification) and pediatric plans (iPSP/PIP).
• Monitor evolving global regulatory guidance for cell and gene therapy and ophthalmology, assess impact on Ocugen programs, and recommend mitigation strategies.

Clinical Trial Applications & Submissions

• Own the preparation and maintenance of INDs and clinical trial applications, including protocol and information amendments and EU CTR submissions.
• Author and review clinical and safety content for regulatory submissions, including clinical summaries, briefing documents, and responses to health authority questions; review CSRs and RMPs for regulatory adequacy.
• Contribute to the clinical sections of marketing applications (BLA/MAA), including Module 2.5, Module 2.7, and Module 5 planning.
• Ensure timely fulfillment of clinical regulatory commitments, including IND annual reports, DSURs, and clinical trial registry requirements.

Health Authority Interactions

• Lead preparation of meeting requests and briefing packages for FDA, EMA, Health Canada, and other agencies (e.g., pre-IND, Type B/C, End-of-Phase 2, Scientific Advice).
• Participate in health authority meetings and, as assigned, serve as a point of contact for agency correspondence; coordinate timely responses to information requests and clinical hold questions.

Collaboration & Leadership

• Partner with Clinical Development, Clinical Operations, Safety/Pharmacovigilance, CMC, Quality, Medical Writing, and Regulatory Operations to align on regulatory deliverables and timelines.
• Work with Regulatory Operations on submission planning and eCTD publishing timelines.
• Develop and maintain regulatory procedures, templates, and best practices for clinical submissions.
• Mentor junior regulatory staff and oversee regulatory consultants or vendors as needed.

Qualifications

• Bachelor’s degree in life sciences required; advanced degree (MS, PhD, PharmD) preferred.
• 8+ years of experience in Regulatory Affairs within biotechnology or pharmaceuticals, with significant experience supporting clinical-stage programs.
• Direct experience with gene therapy, cell therapy, or other biologics; ophthalmology experience a plus.
• Proven hands-on experience preparing and maintaining INDs and CTAs, and contributing to BLA and/or MAA submissions.
• Demonstrated experience preparing for and participating in health authority meetings (FDA and EMA preferred).
• Working knowledge of FDA, EMA, ICH, and EU CTR requirements; familiarity with Health Canada and PMDA a plus.
• Experience with expedited programs (e.g., RMAT, Fast Track, PRIME) and pivotal/late-stage programs strongly preferred.
• Working understanding of CMC regulatory requirements sufficient to integrate with clinical regulatory strategy.
• Excellent written and verbal communication skills, with the ability to influence cross-functional partners and senior leaders.
• Strong organizational skills, with the ability to manage multiple programs, anticipate regulatory risks, and provide practical solutions.

 

Working Conditions

This position operates in an office setting, in person, primarily Monday – Friday during normal business hours. The role may additionally require availability outside of normal business hours to handle priority business needs, including health authority timelines.

 

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.