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  • English
  • Dutch (Netherlands)

Regulatory Affairs

A Regulatory Affairs professional can be involved in all of the following activities, depending on his or her academic background; previous experience and personal skills:

  • Compilation and coordination of applications to regulatory authorities world-wide
  • Preparation and review of administrative and technical regulatory documents
  • Advice on regulatory and drug development strategy
  • Interaction with regulatory authorities on behalf of clients
  • Management of regulatory projects, including oversight of the regulatory project team; control of budget; contract management etc.
  • Training of clients on subjects within the area of expertise
  • Life Sciences or Science Degree
  • Previous experience in Regulatory Affairs or related disciplines is an asset
  • Good command of English (verbal and written)
  • Strong communication skills (verbal / written)
  • Ability to give careful attention to detail and accuracy
  • Strong leadership skills
  • Good organisational and planning skills
  • Good negotiating skills and the ability to identify and resolve issues, using flexible adaptable approach
  • Strong team player
  • Self motivated and assertive
  • Creative and the ability to think ‘outside the box’