Regulatory Affairs Officer at IQVIA (formerly QuintilesIMS)

Expires in 4 days

You will be the support of the regulatory activities within the organization:

  • Preparation, submission and follow-up of registration dossiers for medicinal products in Benelux (new applications, variations and renewals)
  • Maintenance of a database for registered technical details
  • Adaptation and verification of SPC, PIL and packaging materials
  • Implementation of labelling of marketed products following approval
  • Support for pharmacovigilance activities
  • Assistance in SOP writing
  • Follow-up of legislation
  • Development of expertise in specific areas such as nutrients

Profile:
  • Pharmacist or Master degree in pharmaceutical sciences
  • Experience in regulatory affairs is an asset
  • Knowledge of regulations for pharmaceutical products
  • Accurate and efficient
  • Flexible, dynamic, organized, team player
  • Very good knowledge of Dutch, French and English
  • You will report to the Regulatory Affairs Director