Global Director, Regulatory Affairs – RNA Therapeutics

ProQR Therapeutics NV; Leiden; Remote; EUR 140,000 - 190,000; Full time

Benefits offered by this job

Annual performance bonus

Stock options

Premium pension plan

Commuting allowance

Unlimited snacks and beverages

Employee events

Job summary

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

Qualifications

• 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.

Responsibilities

• 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.

Skills

Strategic thinker

Regulatory strategy

Cross-functional leadership

Communication in English

Education

Degree in scientific or health-related field

Postgraduate qualification preferred

Job description

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