Director, Regulatory Affairs

About Ocugen Netherlands B.V.
Ocugen Netherlands B.V. is the European subsidiary of Ocugen, Inc., a U.S.

-based biotechnology company focused on developing innovative gene and cell therapies and vaccines to improve patients’ lives. Our work includes advancing novel treatments for serious retinal diseases with significant unmet medical needs. We are establishing our European operations in Amsterdam to support clinical development, regulatory activities, and future commercialization. Joining our growing team offers the opportunity to help build our European presence, collaborate with colleagues across the United States and internationally, and contribute to bringing potentially transformative therapies to patients.

This position is based onsite at our Amsterdam office, with in-office attendance expected.

Position Summary
Ocugen is seeking an experienced Director, Regulatory Affairs to lead regulatory strategy and execution for innovative gene therapy products and Advanced Therapy Medicinal Products (ATMPs) across the European Union and United Kingdom. Based in Amsterdam, this individual will play a critical role in advancing Ocugen’s clinical‑stage programs toward European registration, including preparation for Marketing Authorization Application (MAA) submissions. The Director will serve as a senior regulatory leader for assigned gene therapy programs, providing strategic regulatory guidance from early development through clinical development, marketing authorization, and post‑approval activities.

The role will have significant responsibility for developing and executing regulatory strategies with European Medicines Agency (EMA) and UK Medicines and Healthcare products Regulatory Agency (MHRA), as well as coordinating regulatory activities across cross‑functional global development teams. The successful candidate will bring strong knowledge of the regulatory and scientific considerations associated with gene therapy, including product characterization, manufacturing and CMC, clinical development, nonclinical requirements, pharmacovigilance, and long‑term follow‑up.

This is a hands‑on role for an individual who can build structure, identify regulatory requirements and gaps, manage complex submission activities, and drive cross‑functional teams toward critical regulatory milestones.

Regulatory Strategy & Leadership

Develop and implement comprehensive regulatory strategies for gene therapy/ATMP programs across the EU and UK.

Provide strategic regulatory advice throughout the product lifecycle, from early research and development through clinical development, marketing authorization, and post‑approval.

Lead regulatory assessment of development plans, program risks, regulatory precedents, and emerging requirements.

Translate complex regulatory requirements into clear development strategies and actionable recommendations for senior leadership.

Serve as the primary Regulatory Affairs representative on cross‑functional program teams.

EMA & EU Regulatory Engagement

Lead regulatory interactions with the EMA, including preparation and execution of scientific advice, protocol assistance, PRIME, pre‑submission, and marketing authorization activities as applicable.

Develop regulatory strategies and submission plans for EU centralized procedures.

Lead preparation and review of regulatory briefing packages, meeting requests, responses to questions, and agency correspondence.

Coordinate regulatory strategy across relevant EU member‑state authorities and scientific committees where appropriate.

Maintain awareness of evolving EU requirements for ATMPs, including gene therapy‑specific regulatory expectations.

MHRA & UK Regulatory Strategy

Lead regulatory strategy and interactions with the MHRA for gene therapy…