Senior Director Regulatory Affairs - Clinical

OCUGEN OPCO INC•East Whiteland Township, PA

1d•Onsite

About The Position

The Senior Director, Regulatory Affairs – Clinical Development leads global clinical regulatory strategy for assigned programs in Ocugen’s retinal gene therapy portfolio, including modifier gene therapies for inherited and degenerative retinal diseases. The role works closely with Clinical Development, Clinical Operations, Biometrics, and Safety to determine the clinical evidence needed to support registration and how to generate it. It requires substantial experience applying regulatory judgment to clinical development, including shaping pivotal study designs, leading substantive FDA discussions, and translating agency feedback into decisions about studies and analyses needed to support a marketing application.

Requirements

Bachelor’s degree in life sciences or a related discipline.
At least 12 years of progressive Regulatory Affairs experience in biotechnology or pharmaceuticals, including substantial responsibility for clinical regulatory strategy.
Demonstrated ownership of clinical regulatory strategy for at least one pivotal or registration-directed program.
Experience shaping study design, endpoint selection, or the evidence plan for registration and explaining the rationale for those decisions.
Firsthand experience leading substantive FDA discussions on clinical development and translating agency feedback into decisions about a development plan, protocol, analysis, or filing strategy.
Hands-on leadership of clinical content for a BLA, NDA, or MAA, including assessing whether efficacy and safety evidence supports the proposed indication.
Ability to critically evaluate protocols, statistical analysis plans, clinical study reports, and efficacy and safety data, and explain their implications for regulatory strategy to scientific and executive audiences.

Responsibilities

Own clinical regulatory strategy for assigned programs from clinical development through registration.
Define the proposed path to registration, identify evidence gaps, and recommend how and when to address them.
Partner with Clinical Development and Biometrics on study design, patient populations, endpoints, comparators, follow-up duration, and analysis plans.
Evaluate whether proposed studies and analyses can support the intended indication and labeling claims.
Lead clinical regulatory strategy for interactions with FDA, EMA, and other health authorities, including defining questions and positions, guiding briefing packages, and leading clinical discussions at key milestones.
Interpret health authority feedback and translate it with program teams into changes to development plans, protocols, analyses, or submission plans.
Document commitments and ensure they are reflected in program timelines.
Direct clinical content of INDs, clinical trial applications, and marketing applications.
Lead clinical regulatory review of protocols, clinical study reports, clinical overviews and summaries, and responses to agency questions.
Ensure efficacy and safety evidence supports a coherent benefit-risk assessment.
Identify and escalate clinical regulatory risks early; present senior leadership with recommendations and explain implications for trial design, timelines, and registration.
Evaluate expedited programs, regulatory designations, and pediatric development requirements as appropriate.
Coordinate with CMC, Nonclinical, Quality, Medical Writing, and Regulatory Operations so the clinical strategy is reflected in overall development and submission plans.