Regulatory Submissions Lead — RA Ops & Strategy

ProQR Therapeutics NV; Leiden; On-site; EUR 100,000 - 140,000; Full time

Benefits offered by this job

8% holiday allowance

30 vacation days

Annual performance bonus

Stock options

Pension plan

Commuting allowance

Staff restaurant

Snacks & drinks

Employee events

Job summary

ProQR Therapeutics in Leiden, NL, is seeking a Manager or Associate Director Regulatory Affairs Operations and Submissions to lead submission planning, coordination and delivery across the pipeline. You will ensure content, timelines and governance are aligned with strategic goals.

You will work with Regulatory Strategy, Clinical, CMC, Nonclinical, Safety and Medical Affairs, shaping scalable processes and knowledge management while partnering with leadership to drive high-quality submissions

Qualifications

• Minimum 6-8 years of Regulatory Affairs experience with submission operations and coordination.
• Degree in a scientific or health-related discipline.
• Experience planning, coordinating and tracking regulatory submissions (INDs/CTAs) across regions.
• Experience managing submission content, authoring workflows, review cycles and health authority queries (preferably in an eCTD environment).
• Experience coordinating cross-functional inputs across Clinical, CMC, Nonclinical, Safety and Medical Affairs.

Responsibilities

• Lead planning, coordination and delivery of regulatory submissions.
• Develop governance, processes and knowledge management for submissions.
• Collaborate with regulatory strategists and cross-functional teams to ensure timely, high-quality submissions.

Skills

Regulatory submissions

Regulatory coordination

Cross-functional collaboration

eCTD publishing

Regulatory systems

English proficiency

Project management

Attention to detail

Time management

Education

Science/health degree

Tools

eCTD software

Job description

ProQR Therapeutics in Leiden, NL, is seeking a Manager or Associate Director Regulatory Affairs Operations and Submissions to lead submission planning, coordination and delivery across the pipeline. You will ensure content, timelines and governance are aligned with strategic goals.

You will work with Regulatory Strategy, Clinical, CMC, Nonclinical, Safety and Medical Affairs, shaping scalable processes and knowledge management while partnering with leadership to drive high-quality submissions