Director, EU Regulatory Affairs – Gene Therapy

Ocugen; Amsterdam; On-site; EUR 180,000 - 240,000; Full time

Job summary

Ocugen Netherlands B.V. is seeking an experienced Director of Regulatory Affairs in Amsterdam to lead regulatory strategy and execution for gene therapy/ATMP programs across the EU and UK.

The role focuses on MAA submissions, scientific advice, and ongoing regulatory leadership within cross‑functional teams. The ideal candidate has 10+ years of biotech regulatory experience, deep knowledge of EMA/UK processes, and a track record of successful major submissions.

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.

Responsibilities

• Provide strategic and operational leadership for major regulatory submissions (EU/UK MAAs, IND/CTA activities, scientific advice).
• Lead regulatory strategy development for gene therapy/ATMP programs across EU and UK.
• Coordinate regulatory activities with EMA, MHRA, and cross‑functional teams.
• Mentor regulatory affairs professionals and engage with global program teams.
• Monitor evolving EU/UK regulatory requirements and regulatory intelligence.

Skills

Regulatory strategy

Regulatory leadership

EMA knowledge

UK MHRA

Global regulatory

Education

Advanced degree in science/regulatory

Job description

Ocugen Netherlands B.V. is seeking an experienced Director of Regulatory Affairs in Amsterdam to lead regulatory strategy and execution for gene therapy/ATMP programs across the EU and UK.

The role focuses on MAA submissions, scientific advice, and ongoing regulatory leadership within cross‑functional teams. The ideal candidate has 10+ years of biotech regulatory experience, deep knowledge of EMA/UK processes, and a track record of successful major submissions.