For one of our clients in Diegem we are looking for an experienced Regulatory Affair Officer.
Job Description
In order to apply for the pharma license for a new legal entity, our client needs a Regulatory Officer to do the preparation of the dossiers and all the external communication.
On the other hand, the required documentation should be created for the new legal entity.
Responsibilities
- Preparation of the elements required to apply for a GDP/WDL license for the future affiliate, to ensure "right first time" & timely submission of the file.
- Application for the GDP pharma license of the new legal entity.
- Answers to the questions in case of questions by the BE Health Authorities (AFMPS/FAGG).
- Development of local Quality Documents to be part of the future "Quality Management System" in the affiliate.
- Application and communication with Health Authorities (is done in Dutch).
Requirements
- Senior RA experience: As from 5 years experience with these responsibilities.
- Very good level of Dutch and English. French is a plus.
- Good communication skills, both written and oral, as well as good listening skills.
- Ability to develop positive and constructive relationships transversally.
Benefits
- Consultancy or freelance
- Full Time or 80%
Existing right to work in Europe required ( please read job spec in full before applying ).
