Regulatory Affairs Project Leader

As a Regulatory Affairs Project Leader, you will contribute to the successful development and regulatory approval of our gene therapy products. You will partner cross-functionally to ensure that regulatory strategies, submissions, and interactions with health authorities worldwide are well-coordinated, proactive, and compliant. In this role, you will be responsible for leading regulatory projects, providing regulatory expertise and guidance, as well as managing regulatory submissions and commitments. You will collaborate closely with internal stakeholders, such as Research & Development, Manufacturing, Quality, and Medical Affairs teams, to ensure efficient and effective regulatory processes.

uniQure is the leader in the field of gene therapy, delivering innovative treatments for patients with severe medical needs. As pioneers in this technology, we are dedicated to developing life-changing therapies and transforming the lives of patients worldwide. Our team of passionate and talented individuals works tirelessly to advance our pipeline of gene therapy candidates and bring hope to those affected by devastating diseases.