Geplaatst op

11 dagen geleden

Locatie

Leiden, ZH

Beschrijving

In the position of Regulatory Affairs 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 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 Boston (USA) ideally. Virtual working would be an option for the right candidate.

We expect our Regulatory Affairs 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 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.