ocugen

# Associate Director Regulatory Affairs -Gene TherapyMain Corporate Office - Malvern, PA 19355## Description**Purpose**The Associate Director of Regulatory Affairs – Gene Therapy will support the development and execution of regulatory strategy for Ocugen’s gene therapy portfolio. This role is responsible for driving regulatory submissions, providing...

Ocugen, Inc. seeks an Associate Director Regulatory Affairs – Gene Therapy to lead global regulatory strategy for our gene therapy portfolio. This onsite role in Malvern, PA collaborates with Clinical, CMC, Quality, and Regulatory Operations to drive IND, BLA, and MAA submissions and prepare agency interactions. The ideal candidate has 8+ years in...

Job Details: Job Location: Main Corporate Office - Malvern, PA, Position Type: Full Time, Salary Range: Undisclosed, Position Summary We are seeking an experienced CMC leader to drive BLA-stage readiness for AAV gene therapy programs. This role serves as the strategic technical interface between laboratory development, GMP manufacturing, regulatory affairs,...

Senior Clinical Data ManagerThe Senior Clinical Data Manager plays a pivotal role within Ocugen's clinical data management team. This individual will lead data management efforts, oversee quality data collection and management processes, and contribute to critical aspects of clinical trial data handling, including database design, CRF development, data...

PurposeThe In-House Clinical Research Associate supports the planning, execution, and closeout of Ocugen clinical studies to ensure study quality, timelines, and regulatory compliance. These activities are performed in accordance with the study protocol, Ocugen standard operating procedures (SOPs), ICH/GCP guidelines, and applicable regulatory...

# Associate Director Regulatory Affairs -Gene TherapyMain Corporate Office - Malvern, PA 19355## Description**Purpose**The Associate Director of Regulatory Affairs – Gene Therapy will support the development and execution of regulatory strategy for Ocugen’s gene therapy portfolio. This role is responsible for driving regulatory submissions, providing...

Ocugen, Inc. seeks an Associate Director Regulatory Affairs – Gene Therapy to lead global regulatory strategy for our gene therapy portfolio.This onsite role in Malvern, PA collaborates with Clinical, CMC, Quality, and Regulatory Operations to drive IND, BLA, and MAA submissions and prepare agency interactions. The ideal candidate has 8+ years in...

Position SummaryThe clinical scientist will support clinical development programs through data-driven insights, analysis, and high-impact visual communication. This role is responsible for retina development and trials data analysis, parsing and interpreting clinical trial data, generating figures and presentations, and supporting data review activities to...

Ocugen Opco Inc. seeks a Manager, Scientific/Medical & Scientific Writing to lead and contribute to planning, authoring, review, and finalization of regulatory documents across development programs. You will ensure cross-project consistency in document standards and support submissions with scientifically rigorous content. Responsibilities include...

Position SummaryThe Manager, Scientific/ Medical & Scientific Writing plays a critical role in ensuring the clarity, accuracy, and strategic alignment of clinical and regulatory documentation across development programs. This individual will lead and contribute to the planning, authoring, review, and finalization of high-quality documents supporting...

# Associate Director Regulatory Affairs -Gene TherapyMain Corporate Office - Malvern, PA 19355## Description**Purpose**The Associate Director of Regulatory Affairs – Gene Therapy will support the development and execution of regulatory strategy for Ocugen’s gene therapy portfolio. This role is responsible for driving regulatory submissions, providing...

Ocugen, Inc. seeks an Associate Director Regulatory Affairs – Gene Therapy to lead global regulatory strategy for our gene therapy portfolio.This onsite role in Malvern, PA collaborates with Clinical, CMC, Quality, and Regulatory Operations to drive IND, BLA, and MAA submissions and prepare agency interactions. The ideal candidate has 8+ years in...

Ocugen seeks an In-House Clinical Research Associate to support planning, execution, and closeout of clinical studies, ensuring quality and regulatory compliance. You will work with cross-functional teams, assist with site identification, feasibility, recruitment, and maintain CTMS/TMF documentation, while ensuring inspection readiness and adherence to...

PurposeThe In-House Clinical Research Associate supports the planning, execution, and closeout of Ocugen clinical studies to ensure study quality, timelines, and regulatory compliance. These activities are performed in accordance with the study protocol, Ocugen standard operating procedures (SOPs), ICH/GCP guidelines, and applicable regulatory...

Position SummaryThe clinical scientist will support clinical development programs through data-driven insights, analysis, and high-impact visual communication. This role is responsible for retina development and trials data analysis, parsing and interpreting clinical trial data, generating figures and presentations, and supporting data review activities to...

Ocugen Opco Inc. is seeking a Clinical Trial Manager to lead the operational execution of multi-site studies from initiation to close-out. You will oversee cross-functional teams, vendor relationships, budgets, and timelines to ensure high-quality data and regulatory compliance. This role requires a life sciences degree, 5+ years in clinical research, and 2+...

Ocugen Opco Inc. seeks a TMF Lead to manage Trial Master Files across studies, ensuring completeness and inspection readiness within Veeva Vault eTMF. You will work with Clinical Operations, Regulatory Affairs, and CROs to optimize TMF processes. Ideal candidates have 5–7 years in TMF operations, strong ICH-GCP knowledge, and hands-on Veeva Vault...

Clinical Trial Manager The Clinical Trial Manager (CTM) is responsible for the overall operational management and execution of clinical trials from initiation through close-out. This includes leading the cross-functional study team, managing vendor and site performance, maintaining budget and timelines, and ensuring high-quality data and regulatory...

Position SummaryThe Clinical Trial Manager (CTM) is responsible for the overall operational management and execution of clinical trials from initiation through close-out. This includes leading the cross-functional study team, managing vendor and site performance, maintaining budget and timelines, and ensuring high-quality data and regulatory compliance. The...

Clinical Scientist Main Corporate Office - Malvern, PA 19355 Position Summary The clinical scientist will support clinical development programs through data-driven insights, analysis, and high-impact visual communication. This role is responsible for retina development and trials data analysis, parsing and interpreting clinical trial data, generating figures...