Director, Regulatory Affairs - RNA Therapeutics

ProQR Therapeutics NV; Leiden; On-site; EUR 120,000 - 170,000; Full time

Benefits offered by this job

8% holiday allowance

30 vacation days

Annual performance bonus

Stock options

Pension plan

Commuting allowance

Subsidized staff restaurant

Unlimited snacks and drinks

Employee events

Job summary

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

Qualifications

• 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.

Responsibilities

• 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.

Skills

Strategic thinking

Regulatory strategy

Cross-functional collaboration

Regulatory leadership

Regulatory negotiations

Communication

Risk assessment

Education

Science/health degree

Postgraduate qualification preferred

Job description

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