(Associate) Director Regulatory Affairs
ProQR Therapeutics is a clinical-stage biotech company listed on NASDAQ with offices in Leiden, the Netherlands and Cambridge, Massachusetts, US. ProQR is focused on the development of game changing RNA therapies for severe genetic rare diseases. Our mission is to help patients by creating new medicines. A team of 160 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 patients we serve.
Our Regulatory Affairs department is currently looking for an Associate Director Regulatory Affairs (full-time) to join our team.
In the position of Regulatory Affairs Associate Director, you will be accountable for the development and implementation of the regulatory strategy for one or more products in line with the objectives set by the project team and with the Company regulatory strategy, and for ensuring that the strategy is designed to deliver a rapid approval with a desired label. You will actively participate in the facilitation of effective partnerships within the regulatory affairs function of ProQR and the drug development teams. To accomplish this, the Regulatory Affairs Associate Director works with other Regulatory staff and with teams to develop and execute the regulatory strategy in order to guide drug development into registration. Additionally, the Regulatory Affairs Director will be responsible for communication and interactions with FDA, EMA and other national Regulatory Authorities.
Location: Leiden, NL or remotely based.
We expect our Regulatory Affairs Associate Director to:
• promote a global mindset
Skills and competencies required for making the difference:
• In the role you must maintain a high level of professionalism, efficiency, and commitment
In hiring new employees, we look for people who are also inspired by our mission and who would fit in well with the collaborative, rigorous and entrepreneurial spirit of the company culture. You must have a minimum of an undergraduate degree in a scientific discipline (B.Sc.), but a graduate degree (M.Sc., Ph.D.) is preferable. You have a minimum of 7 years industry experience in regulatory affairs in the pharmaceutical/biotechnology industry, and proven experience in driving MAA/NDA submission. Experience with orphan drugs is highly valued.
ProQR as an employer
We offer an exciting and innovative working environment in a very committed organization, with the following benefits:
Do you think you can contribute in 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 Laura Faber via firstname.lastname@example.org if you have any questions.