Regulatory Affairs Specialist (Home-based)

For one of our clients, whose headquarters is situated in the Netherlands, we are looking for 2 Regulatory Affairs Specialists to coordinate the regulatory activities in Belgium (home-based). Open for freelancers!

  • Do you have a first experience in the Regulatory Affairs  in the Pharma (generics)?
  • Are you quickly available and can you work independently?
  • Do you have a good knowledge of languages (NL/ENG/FR)?

Then this could be the ideal project for you!

Responsibilities 
  • Support of headquaters for applications for new registrations & maintenance ( variations & renewals) of dossiers for MRP/DCP/CP registered products
  • Creation, submission and follow-up of variations / renewals for nationally authorised products
  • Dealing with national closing at the Belgian agency (FAMHP) after MRP/DCP procedure is finished to obtain marketing authorization
  • Revision of translations of product information (SmPC, PIL & labelling)
  • Partly support of pharmacovigilance, medical information, complaint handling for belgian territory.
Profile 
  • You have at least 2 years of experience in the Regulatory Affairs (Pharma/generics)
  • You can work independently
  • You have strong communication skills
  • You have a good knowledge of languages (NL/FR/ENG), German is a plus
  • You are quickly available
Contact Information 

Ellie Depape

t +3215 21 11 04

m ellie.depape@valesta.com

Application form : Regulatory Affairs Specialist (Home-based)

Files must be less than 3 MB.
Allowed file types: txt rtf html pdf doc docx odt.
Files must be less than 3 MB.
Allowed file types: txt rtf html pdf doc docx odt.
Please read our disclaimer.