Associate Director Regulatory Affairs -Gene Therapy

OCUGEN OPCO INC•East Whiteland Township, PA

92d•Onsite

About The Position

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 strategic input on clinical and CMC programs, and ensuring compliance with global regulatory requirements. Working cross-functionally with Clinical, CMC, Quality, and Regulatory Operations, the Associate Director will play a key role in advancing regulatory filings, preparing for agency interactions, and supporting accelerated pathways to bring Ocugen’s therapies to patients. This is an onsite role.

Requirements

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.
Proven hands-on experience with IND, IMPD, BLA, and/or MAA submissions.
Strong understanding of regulatory requirements in clinical and CMC domains, with ability to contribute to both.
Familiarity with global regulatory agency requirements, including FDA, EMA, Health Canada, and PMDA.
Excellent organizational, written, and verbal communication skills with the ability to influence cross-functional partners.
Ability to manage multiple priorities, anticipate regulatory risks, and provide practical solutions.
Demonstrates adaptability, integrity, and the ability to work independently while fostering cross-functional collaboration.

Nice To Haves

Experience with pivotal/late-stage programs a plus.

Responsibilities

Contribute to the design and execution of global regulatory strategy for Ocugen’s gene therapy programs.
Collaborate with Clinical Development, Clinical Operations, CMC, Quality Assurance, and Project Management to prepare regulatory sections for INDs, IMPDs, BLAs, MAAs, briefing documents, and responses to agency questions.
Drive the preparation, authoring, and review of high-quality regulatory documents to support development, registration, and lifecycle management.
Support health authority interactions (FDA, EMA, Health Canada, PMDA), ensuring alignment with regulatory expectations and preparation of meeting packages.
Monitor evolving regulatory requirements, proactively assess risk, and provide recommendations for mitigation.
Author, review, and manage clinical and safety-related documents such as CSRs, RMPs, clinical summaries, and regulatory briefing packages.
Provide regulatory input on study designs, endpoints, and clinical development plans.
Support regulatory applications and amendments for clinical trials, including EU CTR compliance.
Assist with accelerated regulatory pathways (e.g., Orphan Drug, Fast Track, RMAT, PRIME, ATMP) to expedite development.
Ensure fulfillment of regulatory commitments, including annual reports, DSURs, and clinical trial registry compliance
Support the development and execution of CMC regulatory strategies for gene therapy products.
Contribute to authoring and reviewing CMC sections of submissions, ensuring compliance with scientific and regulatory standards.
Partner with Product Development, Manufacturing, Supply Chain, and QA to align CMC documentation with program timelines and regulatory expectations.
Partner with cross-functional teams (Clinical, CMC, QA, Regulatory Ops, Medical Writing) to align on regulatory deliverables and timelines.
Support the development and maintenance of regulatory best practices, templates, and procedures.
Keep internal teams updated on global regulatory requirements and emerging industry practices.
Represent Ocugen in regulatory discussions and contribute to external advisory forums where appropriate.