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 Ocugens 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.

Responsibilities

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 programs.

- Support UK clinical trial applications, scientific advice, marketing authorization activities, and post-approval regulatory requirements.

- Develop UK-specific regulatory strategies while ensuring appropriate alignment with the global development and EU regulatory strategy.

- Monitor evolving UK regulatory requirements and assess their impact on development programs.

Gene Therapy / ATMP Expertise

- Provide regulatory leadership across gene therapy modalities, including viral-vector and/or non-viral gene therapy platforms.

- Provide strategic input into regulatory considerations for:

Product characterization and potency

- Vector design and manufacturing

- CMC and analytical strategy

- Biodistribution and shedding

- Immunogenicity

- Nonclinical development

- Clinical trial design

- Dose selection and escalation

- Long-term follow-up

- Risk management and pharmacovigilance

- Partner closely with CMC, Clinical Development, Nonclinical, Quality, Safety/PV, and Manufacturing teams to ensure integrated regulatory strategies.

Regulatory Submissions

- Provide strategic and operational leadership for major regulatory submissions, including:

Clinical Trial Applications / associated EU and UK submissions

- Scientific advice packages

- IND/CTA-related regulatory activities

- Marketing Authorization Applications (MAA)

- Orphan designation applications, where applicable

- Pediatric regulatory activities, where applicable

- Post-approval variations and commitments

- Ensure submissions are scientifically sound, strategically aligned, high quality, and delivered according to established timelines.

- Lead preparation and review of key regulatory documents and agency responses.

Cross-Functional & Global Leadership

- Partner with Clinical, CMC, Quality, Nonclinical, Medical Affairs, Safety/PV, Commercial, and Manufacturing functions.

- Provide regulatory leadership within global program teams and governance forums.

- Influence development strategy through a strong understanding of regulatory precedent, benefit-risk considerations, and agency expectations.

- Build productive relationships with internal stakeholders and external regulatory consultants and partners.

- Mentor and develop Regulatory Affairs professionals as appropriate.

Regulatory Intelligence

- Monitor emerging EMA, MHRA, EU, and UK regulations, guidance, scientific developments, and regulatory precedents relevant to gene therapy and ATMPs.

- Evaluate regulatory intelligence and communicate potential impacts to program teams and senior management.

- Develop regulatory positions and recommendations in areas where regulatory precedent is limited or evolving.

Qualifications

- Advanced degree in a relevant scientific, medical, pharmaceutical, or regulatory discipline preferred.

- Typically  10+ years of pharmaceutical/biotechnology regulatory experience , with significant experience in innovative biologics, cell therapy, gene therapy, or ATMPs.

- Demonstrated experience developing regulatory strategies for complex biotechnology products.

- Demonstrated experience supporting late-stage clinical development and major EU regulatory submissions.

- Hands-on experience contributing to or leading preparation of an MAA or substantial MAA components is strongly preferred.

- Practical knowledge of the EMA centralized procedure, eligibility requests, Scientific Advice, Pediatric Investigation Plans, and regulatory authority interactions.

- Experience developing and managing regulatory strategies, submission plans, timelines, dependencies, and cross-functional deliverables.

- Demonstrated ability to prepare, critically review, and coordinate complex regulatory documents and agency communications.

- Experience participating in regulatory authority meetings and converting agency feedback into actionable development and submission plans.

- Strong understanding of the relationship among clinical, nonclinical, safety, CMC, quality, and regulatory requirements during late-stage development.

- Experience working across European and US-based functions in a global development environment.

- Excellent written and verbal communication skills in English.

Working Conditions

This position operates in an office setting, in person. Job may additionally require incumbent to be available outside of these hours to handle priority business needs.

Ocugen is an equal opportunity employer. In order to provide equal employment and advancement opportunities to all individuals, we make all of our employment decisions based upon merit, qualifications, abilities, and an individual’s conduct and performance. We will not make any of our decisions, and will not discriminate against any employee or applicant, on the basis of race, color, religion, creed, national origin or ancestry, ethnicity, sex (including pregnancy), gender (including sexual orientation, gender identity and status as a transgender or transsexual individual), age, physical or mental disability, citizenship, past, current or prospective service in the uniformed services, genetic information, or any other characteristic protected from discrimination under the law. Ocugen complies with applicable federal, state and local laws governing nondiscrimination in employment.