Director Regulatory Affairs

ProQR Therapeutics NV; Leiden; A distancia; EUR 140.000 - 190.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Annual performance bonus

Stock options

Premium pension plan

Commuting allowance

Unlimited snacks and beverages

Employee events

Descripción de la vacante

ProQR Therapeutics is seeking a Director of Regulatory Affairs to lead strategic regulatory development for its rare disease RNA therapies. You will shape development pathways, translate data and objectives into integrated regulatory strategies, and guide teams toward scientifically robust and commercially meaningful outcomes.

Reporting to the Vice President Regulatory Affairs, you will engage with health authorities across global programs, contribute to submission readiness, and help grow the

Formación

• Minimum of 10 years Regulatory Affairs experience in pharmaceutical/biotech with global drug development.
• Degree in a scientific or health-related field; postgraduate qualification preferred.
• Experience developing regulatory strategy for rare disease, pediatric or RNA/oligonucleotide programs.
• Experience leading regulatory planning across early and late development, incl. first‑in‑human, PoC and registration programs.
• Experience leading interactions with FDA, EMA and other health authorities, incl. pre‑IND/advice, pediatric plans, expedited pathways.
• Experience contributing to high‑quality regulatory submissions (INDs/CTAs; NDA/MAA where applicable).
• Ability to translate regulatory guidance into practical, risk‑based recommendations for cross‑functional teams.
• Excellent written, verbal and presentation skills in English.

Responsabilidades

• Lead strategic regulatory development pathways for assigned programs.
• Translate objectives and data into integrated regulatory strategies.
• Guide cross‑functional teams toward scientifically robust development outcomes.
• Engage with health authorities and internal partners to shape submissions.
• Help grow the Regulatory Affairs function within ProQR.

Conocimientos

Strategic thinker

Regulatory strategy

Cross-functional leadership

Communication in English

Educación

Degree in scientific or health-related field

Postgraduate qualification preferred

Descripción del empleo

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.

About the role:

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.

We expect our Director Regulatory Affairs to have:

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, NDA/MAA or other marketing authorization activities.

Ability to interpret regulatory guidance and precedent and translate it into practical, risk‑based recommendations for cross‑functional teams and senior leadership.

Excellent written, verbal and presentation skills in English, with the credibility to represent programs internally and externally.

Skills and competencies that are required for making the difference:

Strategic thinker who can connect regulatory advice to patient need, development objectives and the intended product label.

Able to operate confidently in uncertainty, identify regulatory opportunities and risks, and make pragmatic recommendations with incomplete information.

Strong collaborator and influencer who builds trusted relationships across functions and with external experts and health authorities.

Able to lead complex, cross‑functional workstreams and maintain focus on the critical path.

Clear, persuasive and precise communicator who can tailor messages from detailed scientific discussions to senior management decisions.

Exceptional attention to detail, with a consistent focus on producing accurate, clear, complete and submission‑ready regulatory documents to a high standard of quality.

Proactive, hands‑on and accountable, with the judgement to know when to seek input or elevate an issue.

Committed to continuous learning, constructive challenge and improving how Regulatory Affairs supports the business.

Patient‑oriented, pragmatic and comfortable working in a fast‑paced biotechnology environment.

ProQR as an employer:

As an employer, we value a diverse workforce in which people are encouraged to develop themselves both personally and professionally. We believe that when people are happy, energized and supported by an environment in which they can thrive, they can achieve extraordinary things.

We are committed to ensuring that no employee, candidate, or job applicant receives less favorable treatment on the grounds of race, age, disability, pregnancy, religion, gender identity and expression, sexual orientation, marriage or civil partnership status. At ProQR we want to create an inclusive culture where everyone can be valued for who they are and in which individual differences and contributions in all forms are recognized and valued.

We offer an exciting and innovative working environment in a very committed organization, with the following benefits:

• An annual performance bonus
• Stock options
• A premium‑free pension plan
• A commuting allowance
• Unlimited (un)healthy snacks and drinks
• Employee events (boot camp, Coffee and Collaboration Café and other social events)

ProQR was founded by Daniel de Boer with a mission to help people living with rare genetic diseases. This remains the sole focus of our company today.

Our passion lies in discovering the latest RNA technologies and translating them to life‑changing treatments for people with severe rare and common diseases.