Regulatory Affairs Assistant

Regulatory Affairs Assistant

We have a fantastic opportunity to join our partner's international Regulatory Affairs team. You will support regulatory aspects of clinical research projects, streamline communication, maintain electronic systems and managing documents for studies in Belgium and the Netherlands.

It concerns a dynamic, global company founded in 1995, that brings together more than 1,700 driven, dedicated and passionate individuals.  They work on the frontline of medical science, changing lives, and bringing new medicines to those who need them.

You will:

  • Act as a point of contact for clinical project teams and support services on regulatory matters
  • Prepare draft regulatory/ethics submission dossiers
  • Be responsible for document management such as filing, processing, translations and quality control
  • Update and maintain (automated) tracking systems, working files, and schedules
  • Organise meetings, prepare agendas and minutes


  • Ideally, you will have a Bachelor degree or an equivalent combination of education, training & experience
  • Prior experience in an administrative role is advantageous, along with experience in, or knowledge of the Clinical Research industry
  • Fully proficient in Dutch and English, and French is beneficial
  • Good working knowledge of MS Office applications
  • The ability to plan, multitask and work in a dynamic team environment
  • Excellent communication and collaboration skills


You will receive a fixed contract at a growing company with true focus on its people. Their benefits are focused on providing you with the support to excel both at work, and in your personal life!

Katleen Broeckhoven

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