Regulatory affairs officer (MA1046)

Reference: MA1046
Region: Belgium
Sector: Pharmaceutical Industry
Type of contract: Permanent - Full Time
Category: Regulatory

We are looking for a regulatory affairs officer with possibilty to work 80%.

Description

  • Assist the Regulatory Affairs Manager in the preparation of registration dossiers, updates or variations of such a dossier, for submission to the Belgian and Luxemburg authorities.
  • Assist the Regulatory Affairs Manager in the maintenance of the marketing authorisations by means of the preparation of the applications for 5 yearly renewals, variations and update and manage the RA database and registration status files.
  • Assist the Regulatory Affairs Manager in the preparation and follow-up of price and reimbursement applications and management status and database related to price and reimbursement files.
  • Prepare the review and approval of publicity and training material.
  • Prepare the product releases, manage complaint handling and general quality assurance tasks.
  • Prepare, review and approve packaging materials in accordance with approvals from Belgian and Luxemburg Health Authorities and archive approved packaging materials.
  • Provide regulatory answers to Marketing and Sales and Business Development concerning the status of Regulatory files or other Regulatory related issues.
  • Provide support for pharmacovigilance.
  • Keep price list updated and disseminate them to all concerned in a timely way every month.
  • Manage and update bibliography and regulations.
  • Help managing the departmental e-drive.
  • In collaboration with and under the direction of the RA Manager ensure that all departmental administration is conducted efficiently, that all procedures are followed and that adequate cover for absences is available. 

Profile

-Meticolous

-Strong in organisation

-Team oriented

-Good communication skills

Education

-Master in sciences

Experience

-Experience in regulatory affairs

Languages

English: Good
Dutch: Good
French: Good

Offer

-Very attractive salary package.

-Possibilty to work 80%