Regulatory Submissions Lead, RA Operations & Governance

ProQR Therapeutics NV; Leiden; On-site; EUR 110,000 - 150,000; 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 NV in Leiden, NL, is seeking a Manager or Associate Director Regulatory Affairs Operations and Submissions to lead planning, coordination and delivery of regulatory submissions and agency interactions across the pipeline. You will partner with regulatory strategists and cross-functional teams to ensure content, people, systems and timelines support high-quality submissions.

Reporting to the VP Regulatory Affairs, you will help establish submission governance, scalable

Qualifications

• A minimum of 6–8 years of Regulatory Affairs experience in pharma/biotech.
• Degree in a scientific, health-related or equivalent discipline.
• Experience planning, coordinating and tracking regulatory submissions across regions (INDs/CTAs).
• Experience managing submission content, document readiness, authoring workflows, reviews, publishing and health authority queries (preferably in an eCTD environment).
• Experience coordinating cross-functional inputs across Clinical, CMC, Nonclinical, Safety, Medical Affairs and others.
• Working knowledge of FDA, EMA and other major regulatory submission requirements and timelines.
• Experience maintaining regulatory systems, trackers, submission plans, commitments and archives; improves processes.
• Strong written and verbal English communication; attention to detail; able to manage competing priorities.

Responsibilities

• Lead planning, coordination and delivery of regulatory submissions and agency interactions.
• Ensure content, people, systems and timelines support high-quality submissions across the pipeline.
• Collaborate with regulatory strategists and cross-functional teams to drive governance and efficient processes.
• Develop scalable submission governance, practical ways of working and knowledge management approaches.
• Shape how Regulatory Affairs operates as the function grows within ProQR.

Skills

Regulatory submissions planning

Cross-functional collaboration

eCTD publishing

Regulatory knowledge (FDA/EMA)

English communication

Attention to detail

Project management

Regulatory systems

Document management

Education

Scientific degree

Tools

eCTD environment

Job description

ProQR Therapeutics NV in Leiden, NL, is seeking a Manager or Associate Director Regulatory Affairs Operations and Submissions to lead planning, coordination and delivery of regulatory submissions and agency interactions across the pipeline. You will partner with regulatory strategists and cross-functional teams to ensure content, people, systems and timelines support high-quality submissions.

Reporting to the VP Regulatory Affairs, you will help establish submission governance, scalable