Manager / Associate Director Regulatory Affairs Operations & Submissions

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

Manager / Associate Director Regulatory Affairs Operations & Submissions

Department Development

ProQR Therapeutics is a NASDAQ-listed biotechnology company headquartered in Leiden, the Netherlands with an office in and Cambridge, Massachusetts, USA.

At ProQR, we are on a mission to edit RNA, treat disease and change lives. A team of 180+ enthusiastic ProQRians from all walks of life and more than 30 different nationalities is committed to pioneering transformative RNA therapies to make a difference in the lives of the communities we serve.

Our proprietary Axiomer™ RNA editing technology platform enables the editing of specific single nucleotides in RNA using the cells own editing machinery. Axiomer RNA editing technology harnesses ADAR (Adenosine Deaminase Acting on RNA), a protein which is present in all human cells, to repair G-to-A mutations, modulate protein, and enable protective mutation functions. Axiomer could potentially yield a new class of innovative medicines and treat currently untreatable diseases. By harnessing the power of RNA editing, we aim to create a world where genetics inform your health - but never limit it.

Our Regulatory Affairs department is currently looking for a Manager / Associate Director Regulatory Affairs Operations and Submissions (Full-time) to join our team (the level of appointment will be determined according to the successful candidate’s experience, expertise and level of independence).

ProQR’s Regulatory Affairs function works across the pipeline to translate innovative science into clear, credible and executable development and submission strategies. The team partners closely with Clinical, Nonclinical, CMC, Safety, Medical Affairs and other functions, as well as external experts and health authorities, to support the development of medicines for people living with rare diseases.

About the role:

The Manager or Associate Director Regulatory Affairs Operations and Submissions will play a central role in supporting ProQR’s growing Regulatory Affairs function. The role will lead the planning, coordination and delivery of regulatory submissions and agency interactions, ensuring that the right content, people, systems and timelines are in place to support high-quality submissions across the pipeline. Working closely with regulatory strategists and cross-functional teams, the successful candidate will bring structure, transparency and momentum to submission execution, while helping to develop scalable processes, systems and knowledge management approaches.

This is an exciting time to join the team as one of its early members. Working closely with the Vice President Regulatory Affairs and colleagues across the business, you will have the opportunity to help shape how the function operates as it develops. In particular, you will contribute to establishing effective submission governance, practical ways of working and strong cross-functional partnerships that will support the team’s growth and the delivery of its objectives across ProQR’s expanding pipeline.

We expect our Manager / Associate Director Regulatory Affairs Operations and Submissions to have:

A minimum of 6-8 years of Regulatory Affairs experience in the pharmaceutical or biotechnology industry, with substantial experience in submission operations and regulatory coordination.

A degree in a scientific, health-related or equivalent relevant discipline.

Practical experience planning, coordinating and tracking regulatory submissions across regions, including INDs/CTAs and supporting materials.

Experience managing submission content, document readiness, authoring workflows, review cycles, publishing, validation, dispatch and health authority queries, preferably in an eCTD environment.

Experience coordinating cross-functional and vendor inputs across Clinical, CMC, Nonclinical, Safety, Medical Affairs and other contributors.

Working knowledge of FDA, EMA and other major regulatory submission requirements and timelines.

Experience maintaining regulatory systems, trackers, submission plans, commitments and archives, with an interest in improving processes and knowledge management.

Strong written and verbal communication skills in English, with excellent attention to detail and the ability to manage competing priorities.

Skills and competencies that are required for making the difference:

Highly organised and dependable, with a strong focus on submission quality, document control and delivery to agreed timelines.

Hands-on and solutions-oriented, willing to take ownership of operational detail while keeping sight of the wider programme objective.

Able to establish clear submission plans, governance and ways of working across internal teams and external partners.

Comfortable coordinating multiple workstreams, dependencies and deadlines in a fast-paced development environment.

Builds positive and effective working relationships across functions, collaborating proactively with colleagues and external partners to coordinate inputs and deliver high-quality submissions on time.

Confident escalating risks early, communicating status clearly and driving actions through to completion.

Strong interest in regulatory systems, eCTD publishing, RIM, document management and practical use of technology to improve efficiency.

Collaborative and service-oriented, with the confidence to challenge unclear inputs or processes constructively.

Patient-oriented, pragmatic and committed to high standards of accuracy and compliance.

ProQR as an employer

As an employer, we value a diverse workforce in which people are encouraged to develop themselves both personally and professionally. We believe that when people are happy, energized and supported by an environment in which they can thrive, they can achieve extraordinary things.

We are committed to ensuring that no employee, candidate, or job applicant receives less favorable treatment on the grounds of race, age, disability, pregnancy, religion, gender identity and expression, sexual orientation, marriage or civil partnership status. At ProQR we want to create an inclusive culture where everyone can be valued for who they are and in which individual differences and contributions in all forms are recognized and valued.

We offer an exciting and innovative working environment in a very committed organization, with the following benefits:

• An annual performance bonus
• Stock options
• A premium-free pension plan
• A commuting allowance
• Unlimited (un)healthy snacks and drinks
• Employee events (boot camp, Coffee and Collaboration Café and other social events)

We are looking for people who are inspired by our mission to edit RNA, treat disease and change lives. Are you up for the challenge?

We are an innovative biotech company headquartered in Leiden, the Netherlands. We focus on the development of life-changing RNA therapies for severe rare and common diseases. Are you up for a challenge?

ProQR was founded by Daniel de Boer with a mission to help people living with rare genetic diseases. This remains the sole focus of our company today.

Our passion lies in discovering the latest RNA technologies and translating them to life-changing treatments for people with severe rare and common diseases.