Director Regulatory Affairs

ProQR Therapeutics NV; Leiden; Presencial; EUR 120 000 - 170 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

8% holiday allowance

30 vacation days

Annual performance bonus

Stock options

Pension plan

Commuting allowance

Subsidized staff restaurant

Unlimited snacks and drinks

Employee events

Resumo da oferta

ProQR Therapeutics, based in Leiden, NL, seeks a Director of Regulatory Affairs to lead strategic regulatory activities for the rare disease RNA-editing programs. The role focuses on shaping development pathways, aligning internal teams with regulatory expectations, and engaging with health authorities to drive submissions and approvals.

As a senior member of the Regulatory Affairs team, you will craft integrated regulatory strategies, guide early to late development plans, and ensure submission

Qualificações

• Minimum 10 years of Regulatory Affairs experience in pharma/biotech.
• Degree in a scientific or health-related discipline; postgraduate preferred.
• Proven ability to develop regulatory strategies for innovative medicines, incl. rare disease/pediatric/RNA programs.
• Experience leading regulatory planning across early and late development.
• Strong track record with FDA, EMA and other health authorities, incl. pre-IND/scientific advice.
• Experience with submissions (INDs/CTAs; NDA/MAA) and briefing materials.
• Ability to translate guidance into practical recommendations for cross-functional teams.
• Excellent written, verbal and presentation skills in English.

Responsabilidades

• Serve as strategic regulatory leader for assigned programs and shape development pathways.
• Translate objectives and data into integrated regulatory strategies.
• Lead health authority engagements and development planning.
• Collaborate with cross-functional teams to support submissions and lifecycle planning.
• Help grow the Regulatory Affairs function and implement practical ways of working.

Conhecimentos

Strategic thinking

Regulatory strategy

Cross-functional collaboration

Regulatory leadership

Regulatory negotiations

Communication

Risk assessment

Formação académica

Science/health degree

Postgraduate qualification preferred

Descrição da oferta de emprego

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.

Location

Leiden, NL (on‑site)

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:

• 8% holiday allowance
• 30 vacation days
• An annual performance bonus
• Stock options
• A premium‑free pension plan
• A commuting allowance
• A subsidized staff restaurant
• Unlimited (un)healthy snacks and drinks
• Employee events (boot camp, Coffee and Collaboration Café and other social events)

We are looking for people who are inspired by our mission to edit RNA, treat disease and change lives. Are you up for the challenge?