Director, EU & UK Regulatory Affairs - Gene Therapy

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

Job summary

Ocugen Netherlands B.V. in Amsterdam seeks an experienced Director, Regulatory Affairs to lead regulatory strategy and execution for gene therapy and ATMPs across the EU and UK.

Based in Amsterdam, you will partner with EMA/MHRA, coordinate cross-functional global teams, oversee submissions, and guide development from early research through post-approval. This hands-on leadership role requires deep regulatory knowledge, strong collaboration, and a track record of delivering complex regulatory

Qualifications

• Advanced degree in a scientific, medical, regulatory discipline.
• 10+ years of pharmaceutical/biotech regulatory experience, including gene therapy/ATMPs.
• Experience leading complex EU regulatory submissions (MAA) and interactions with EMA/MHRA.

Responsibilities

• Develop and implement regulatory strategies for gene therapy/ATMP programs across EU and UK.
• Lead EMA/MHRA interactions, scientific advice, and submissions planning.

Skills

Regulatory strategy

Cross-functional leadership

EU/UK regulatory engagement

Gene therapy/ATMP expertise

Regulatory submissions

Strategic advisory

Education

Advanced degree in regulatory/science

Job description

Ocugen Netherlands B.V. in Amsterdam seeks an experienced Director, Regulatory Affairs to lead regulatory strategy and execution for gene therapy and ATMPs across the EU and UK.

Based in Amsterdam, you will partner with EMA/MHRA, coordinate cross-functional global teams, oversee submissions, and guide development from early research through post-approval. This hands-on leadership role requires deep regulatory knowledge, strong collaboration, and a track record of delivering complex regulatory