Regulatory Affairs Submissions Operations Lead (Manager/AD)

ProQR Therapeutics NV; Leiden; Remote; EUR 110,000 - 140,000; Full time

Benefits offered by this job

Annual performance bonus

Stock options

Premium-free pension plan

Commuting allowance

Unlimited snacks and drinks

Employee events

Job summary

ProQR Therapeutics, a Leiden-based biotechnology company, seeks a Manager/Associate Director Regulatory Affairs Operations and Submissions to lead submission planning, governance, and cross-functional coordination. The role focuses on delivering high-quality regulatory submissions and managing agency interactions across pipelines.

You will drive process improvements, ensure content readiness, and oversee eCTD workflows, partnering with Clinical, CMC, Safety and Medical Affairs teams to meet

Qualifications

• Minimum 6–8 years of Regulatory Affairs experience in pharma/biotech.
• Degree in a scientific, health-related discipline.
• Experience planning, coordinating and tracking regulatory submissions across regions (INDs/CTAs).
• Experience managing submission content, document readiness, authoring workflows, review cycles and health authority queries, preferably in an eCTD environment.

Responsibilities

• Lead planning, coordination and delivery of regulatory submissions and agency interactions across the pipeline.
• Establish submission governance, schedules, and cross-functional collaboration.
• Develop scalable processes, systems and knowledge management for submissions.
• Coordinate inputs from Clinical, CMC, Nonclinical, Safety and Medical Affairs teams and external partners.

Skills

Regulatory submissions

eCTD publishing

Cross-functional coordination

Regulatory systems

Documentation control

Education

Bachelor's degree in scientific/health-related field

Tools

RIM/Regulatory databases

eCTD tooling

Job description

ProQR Therapeutics, a Leiden-based biotechnology company, seeks a Manager/Associate Director Regulatory Affairs Operations and Submissions to lead submission planning, governance, and cross-functional coordination. The role focuses on delivering high-quality regulatory submissions and managing agency interactions across pipelines.

You will drive process improvements, ensure content readiness, and oversee eCTD workflows, partnering with Clinical, CMC, Safety and Medical Affairs teams to meet