Director Regulatory Affairs

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 Director Regulatory Affairs (Full-time) to join our team.

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 Director Regulatory Affairs will be a strategic regulatory leader for assigned ProQR programs, with particular focus on shaping development pathways for our rare disease pipeline. The role will translate program objectives, emerging data and external regulatory expectations into integrated regulatory strategies that guide teams towards scientifically robust and commercially meaningful development outcomes. The successful candidate will combine strategic judgement with hands‑on delivery and will play an important role in health authority engagement, development planning and the continued growth of the Regulatory Affairs function.

This is an exciting time to join the team as one of its early senior members. Working closely with the Vice President Regulatory Affairs and colleagues across the business, you will help translate the department’s overall direction into effective program‑level strategies and contribute to the development of a high‑performing function. You will also have the opportunity to help shape practical ways of working, strengthen cross‑functional partnerships and support the growth of team capability across ProQR’s expanding pipeline.

A minimum of 10 years of Regulatory Affairs experience in the pharmaceutical or biotechnology industry, with significant experience in global drug development.

A degree in a scientific or health‑related discipline; a postgraduate qualification is preferred.

Demonstrated experience developing and implementing regulatory strategy for innovative medicines, ideally including rare disease, pediatric or RNA/oligonucleotide programs.

Experience leading regulatory planning across early and late development, including strategy for first‑in‑human, proof‑of‑concept and registration‑enabling programs.

Strong experience preparing for and leading interactions with FDA, EMA and other health authorities, including pre‑IND or equivalent advice, scientific advice, pediatric plans and expedited development pathways.

Experience contributing to or leading high‑quality regulatory submissions and briefing materials, including INDs/CTAs and, where applicable,…