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!
- 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.
- 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
t +3215 21 11 04