Associate Director Regulatory Affairs at ProQR Therapeutics
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.
We expect our Regulatory Affairs Associate Director to:
• ensure that the content, quality, and format of regulatory submissions comply with applicable regulations and guidelines
• contribute to the design of the development strategy, particularly focusing regulatory aspects, for assigned products
• drive the preparation of regulatory applications, including Orphan Drug Applications, INDs/CTAs, Scientific Advice, Pediatric Investigational Plans and NDA/MAAs
• 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
• contribute to the monitoring of the regulatory landscape to keep abreast of new developments and effectively communicate them across the company
• promote a global mindset
Skills and competencies required for making the difference:
• The RA Associate Director displays strategic leadership skills, with a strong ability to think strategically and critically evaluate regulatory risks in drug development activities
• Excellent knowledge and understanding of US regulatory environments. Familiar with EU regulatory environment.
• Strong knowledge and experience in all phases of drug development
• Experience in MAA/NDA submission and peri-launch phases
• Strong ability to work effectively with multiple disciplines and personalities, works both independently and collaboratively in a team structure
• Innovative, initiative, anticipating problems and effective problem solving, by providing creative solutions
• Able to work in a fast pace environment, strong project planning and management skills, able to prioritize multiple tasks
• Excellent oral and written communication skills
• In the role you must maintain a high level of professionalism, efficiency, and commitment
Who You Are:
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 10 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
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 ensure 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 the 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:
• A competitive salary
• 8% holiday allowance
• 30 vacation days
• An annual performance bonus
• Stock options
• A premium-free pension plan
• A commuting allowance
• A subsidized staff restaurant
• Flexible working arrangements
• Unlimited (un)healthy snacks and drinks
• Employee events (boot camp, chair massage and other social events.
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 via our website if you are interested in this position.
You can contact Laura Faber via email@example.com if you have any questions.