Senior Manager, Regulatory Affairs - Clinical
About The Position
The Senior Manager, Regulatory Affairs – Clinical serves as the regulatory lead for assigned clinical programs within Ocugen’s gene therapy portfolio, including modifier gene therapies for inherited and degenerative retinal diseases. The position develops and executes clinical regulatory strategy, owns clinical trial applications throughout their lifecycle, leads preparation for health authority interactions, and partners with Clinical Development, Clinical Operations, Safety, and Medical Writing to advance programs from clinical development through registration. This is an onsite role at the Main Corporate Office in Malvern, Pennsylvania. The role leads clinical regulatory strategy and submission activities, including preparation and maintenance of INDs and clinical trial applications, clinical content for regulatory submissions, and contributions to BLA/MAA clinical sections. It also coordinates preparation for and participation in health authority meetings and supports cross-functional alignment, regulatory procedures, and the development of junior staff. The position is performed in person in an office setting, primarily Monday through Friday during normal business hours, with possible availability outside those hours for priority business needs, including health authority timelines.
Requirements
- Bachelor’s degree in life sciences.
- At least 8 years of Regulatory Affairs experience within biotechnology or pharmaceuticals, with significant experience supporting clinical-stage programs.
- Direct experience with gene therapy, cell therapy, or other biologics.
- Hands-on experience preparing and maintaining INDs and CTAs, and contributing to BLA and/or MAA submissions.
- Experience preparing for and participating in health authority meetings; FDA and EMA experience preferred.
- Working knowledge of FDA, EMA, ICH, and EU CTR requirements.
- Working understanding of CMC regulatory requirements sufficient to integrate them with clinical regulatory strategy.
- Excellent written and verbal communication skills, including the ability to influence cross-functional partners and senior leaders.
- Strong organizational skills and the ability to manage multiple programs, anticipate regulatory risks, and provide practical solutions.
Nice To Haves
- Advanced degree (MS, PhD, or PharmD).
- Ophthalmology experience.
- Familiarity with Health Canada and PMDA.
- Experience with expedited programs such as RMAT, Fast Track, and PRIME.
- Experience with pivotal and late-stage programs.
Responsibilities
- Develop and execute clinical regulatory strategies for assigned gene therapy programs in alignment with global development plans and corporate objectives.
- Serve as regulatory lead on cross-functional program and study teams, advising 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, including Orphan Drug, Fast Track, RMAT, PRIME, and ATMP classification requests, and pediatric plans (iPSP/PIP).
- Monitor evolving global regulatory guidance for cell and gene therapy and ophthalmology, assess its impact on programs, and recommend mitigation strategies.
- Own 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 clinical sections of marketing applications (BLA/MAA), including Module 2.5, Module 2.7, and Module 5 planning.
- Ensure timely completion of clinical regulatory commitments, including IND annual reports, DSURs, and clinical trial registry requirements.
- Lead preparation of meeting requests and briefing packages for FDA, EMA, Health Canada, and other agencies for meetings such as pre-IND, Type B/C, End-of-Phase 2, and Scientific Advice.
- Participate in health authority meetings and, as assigned, serve as a contact for agency correspondence; coordinate responses to information requests and clinical hold questions.
- Partner with Clinical Development, Clinical Operations, Safety/Pharmacovigilance, CMC, Quality, Medical Writing, and Regulatory Operations to align 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.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
