For the Regulatory Affairs and Quality Assurance department of R&D in Leiderdorp, the Netherlands, we are looking for a Senior Regulatory Affairs Manager with a focus on development.

In this role you are responsible for the strategic regulatory support throughout the entire development, scientific advice procedures, PIP submissions as well as preparation, submission and defense of registration files (Marketing Authorization Applications) according to current legislation, in order to obtain and maintain marketing authorizations. Considering the focus on development you will:

• Participate as a Project Team Member, representing Regulatory Affairs in multi-disciplinary development project teams, brand teams and study teams
• Assess registerability of a new product by preparing a Regulatory Development Plan and ensure registerability.

 

Your personal qualifications:

• Academic qualifications preferably as a pharmacist, chemist or (medical) biologist
• At least 7 years experience with regulatory affairs activities in the pharmaceutical industry and/or with regulatory authorities
• Able to work in a well organized project management result oriented way
• Good communication and writing skills
• Experience with Urology and Pediatric Strategy
• Good knowledge of the regulatory rules, guidances and institutes in the territory

 

We offer:

• A challenging and diversified job
• Good career opportunities
• Inspiring work climate
• Attractive remuneration.