Regulatory Affairs Director (Maternity leave cover)

ProQR Therapeutics is a biotechnology company listed on NASDAQ with offices in Leiden, the Netherlands and Cambridge, Massachusetts, USA. ProQR is focused on the development of life changing RNA therapies to meet the unmet need of individuals and families with common and rare diseases. A team of 150 enthusiastic ProQRians from all walks of life and more than 30 different nationalities is up to this challenge. We have the passion and commitment 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), which is machinery 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.

We are building our development organization in preparation to enter the clinic in late 2024/early 2025, in parallel we are looking for a Regulatory Affairs Director (Full-time) to join us for a 9-12 month period to lead the Regulatory Affairs activities to cover maternity leave.

Location: Leiden, NL (on-site)

The Regulatory Affairs Director will be accountable for the development and implementation of the regulatory strategy for the ProQR pipeline projects, proactively engaging with the project teams, external experts and Regulatory Authorities. The role demands a proactive leader who can navigate the complexities of early clinical-stage programs. In this role, the candidate will:

• Oversee all aspects of Regulatory Affairs in a small and dynamic publicly-listed company.
• Provide expert regulatory input to project teams and senior management to enable the development of the optimal regulatory strategy for programs.

• Lead the activities to support gaining scientific advice including meeting requests, preparation of the briefing book and chairing meetings with the regulatory authorities.
• Lead the preparation of high-quality regulatory applications eg INDs/CTAs and manage the clinical trial approval processes.
• Ensure that the content, quality, and format of regulatory submissions comply with applicable regulations and guidelines.
• Communicate with internal and external partners, including EMA, FDA and other Regulatory Authorities.
• Contribute to the implementation of systems & processes to enhance global business value.
• Monitor the regulatory landscape to keep abreast of new developments and effectively communicate them across the company.
• Provide training on regulatory expectations to Project Team members.

We expect our Regulatory Affairs Director to have:

• An advanced degree (PhD/MSc) in a Life Science or Applied Science discipline.
• A minimum of 10 years of industry experience in regulatory affairs in the pharmaceutical/biotechnology industry with excellent knowledge of multiple Phases of drug development. Ideally, experience working with large pharmaceutical businesses, combined with exposure to smaller companies, with an understanding of the challenges facing an innovative company going through rapid growth.
• Proven experience in chairing meetings with Regulatory authorities and successful CTA/IND submissions.
• Experience in liver/cardiovascular diseases, rare disease drug development, emerging technologies and/or platforms, and the new EU Clinical Trials Regulation would be an advantage.

Skills and competencies that are required to make the difference:

• Excellent written and oral communication
• Strategic & creative thinking, decision making and problem-solving skills
• Flexibility, integrity and a clear sense of accountability
• Results-driven, with a high level of tenacity, enthusiasm and energy
• Cross-functional / matrix leadership skills
• Team player with a hands-on mentality, with the ability to work independently and in a matrix setting
• Patient-oriented attitude
• Being able to work in a fast-paced environment
• Strong project planning and management skills, able to prioritize multiple tasks
• Being a nice person 😊

ProQR as an employer

As an employer, we are a true believer of the value of a workforce in which people from diverse backgrounds are encouraged to develop themselves, personally and professionally. We believe that happy and energized people, working well together in an environment in which they thrive, will do phenomenal and awesome 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.

Do you think you can contribute to achieving our mission? If so, we’re looking forward to receiving your application by filling out our application form. Please apply as soon as possible if you are interested in this position. You can contact Silvia Catellani via recruitment@proqr.com if you have any questions.