Manager​/Associate Director Regulatory Affairs Operations & Submissions

Department Development

ProQR Therapeutics is a NASDAQ-listed biotechnology company headquartered in Leiden, the Netherlands with an office in and Cambridge, Massachusetts, USA.

At ProQR, we are on a mission to edit RNA, treat disease and change lives. A team of 180+ enthusiastic ProQRians from all walks of life and more than 30 different nationalities is committed to pioneering transformative RNA therapies to make a difference in the lives of the communities we serve.

Our proprietary Axiomer™ RNA editing technology platform enables the editing of specific single nucleotides in RNA using the cells own editing machinery. Axiomer RNA editing technology harnesses ADAR (Adenosine Deaminase Acting on RNA), a protein which is present in all human cells, to repair G-to-A mutations, modulate protein, and enable protective mutation functions. Axiomer could potentially yield a new class of innovative medicines and treat currently untreatable diseases.

By harnessing the power of RNA editing, we aim to create a world where genetics inform your health - but never limit it.

Our Regulatory Affairs department is currently looking for a Manager / Associate Director Regulatory Affairs Operations and Submissions (Full-time) to join our team (the level of appointment will be determined according to the successful candidate’s experience, expertise and level of independence).

ProQR’s Regulatory Affairs function works across the pipeline to translate innovative science into clear, credible and executable development and submission strategies. The team partners closely with Clinical, Nonclinical, CMC, Safety, Medical Affairs and other functions, as well as external experts and health authorities, to support the development of medicines for people living with rare diseases.

The Manager or Associate Director Regulatory Affairs Operations and Submissions will play a central role in supporting ProQR’s growing Regulatory Affairs function. The role will lead the planning, coordination and delivery of regulatory submissions and agency interactions, ensuring that the right content, people, systems and timelines are in place to support high-quality submissions across the pipeline. Working closely with regulatory strategists and cross-functional teams, the successful candidate will bring structure, transparency and momentum to submission execution, while helping to develop scalable processes, systems and knowledge management approaches.

This is an exciting time to join the team as one of its early members. Working closely with the Vice President Regulatory Affairs and colleagues across the business, you will have the opportunity to help shape how the function operates as it develops. In particular, you will contribute to establishing effective submission governance, practical ways of working and strong cross-functional partnerships that will support the team’s growth and the delivery of its objectives across ProQR’s expanding pipeline.

A minimum of 6-8 years of Regulatory Affairs experience in the pharmaceutical or biotechnology industry, with substantial experience in submission operations and regulatory coordination.

A degree in a scientific, health-related or equivalent relevant discipline.

Practical experience planning, coordinating and tracking regulatory submissions across regions, including INDs/CTAs and supporting materials.

Experience managing submission content, document readiness, authoring workflows, review cycles, publishing, validation, dispatch and health authority queries, preferably in an eCTD environment.

Experience coordinating…