Advice & reporting for the chemical and pharmaceutical industries

Medical Affairs Officer – Regulatory Affairs

Deadline for applications: 
Tuesday, 31 December, 2019
Job description: 
  • Life cycle support for registered medicinal products (EU regulatory affairs).
  • Creation, adaptation and verification of registration dossiers in e-CTD format (new products, product variations, 5-year renewals).
  • Verification medicinal product artwork and translations.
  • Keep up-to-date with current European and Belgian legislation for medicinal products, medical devices, nutrients, cosmetics...
  • At least a Bachelor’s Degree in life sciences
  • Candidates with proven experience in a comparable function or those who are familiar with the field's concepts, practices, and EU regulatory affairs procedures have an advantage.
  • Outstanding interpersonal and communication (written and verbal) skills are required: the ideal candidate is trilingual (Dutch / French / English) CEFR level B1 or higher.
  • Multitasker, able to cope with a broad range of projects, high stress levels and time pressure. - Diplomatic and flexible personality, proactive, being able to function alone and in a team.
  • Focused on detail and systematic in approach.
  • Proficient with computer and standard software programs (Word, Outlook, Excel,…).
  • Only candidates living in Belgium will be considered.
  • Applications + a detailed cv should be sent in Word format to hr [at] before the expiry date.
  • All applicants will receive a reply.
  • The procedure will involve one or more face-to-face interviews