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.
Location: Leiden, NL (on-site)
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:
8% holiday allowance
30 vacation days
An annual performance bonus
Stock options
A premium-free pension plan
A commuting allowance
A subsidized staff restaurant
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?
Please apply as soon as possible if you are interested in this position.
Submit your application via the Apply button below. Please contact Silvia Catellani via recruitment@proqr.com if you have any questions.
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