What you'll do
Regulatory Affairs Consultant
The open position is located in the Regulatory Affairs Life Cycle Management team covering a portfolio that consist of marketing authorizations maintained within company.
The life cycle activities relates to marketing authorizations (MRP/DCP and CP) in Benelux countries.
As a RA officer your main task is related to:
- Maintenance and ensuring regulatory compliance of marketing authorizations in the assigned territory.
- Cross functional planning with Regulatory Competence Center (RCC-EU), QA, Supply Chain as well as with 3rd party manufactures on variations and renewals
- Prepare and ensure timely submission of national texts and mock-ups for Global products in the Region
- Respond to requests from the authorities
- Text management of national text including preparation and release for print
- Updating of relevant databases (SAP and Access)
- Regulatory assessment of change control cases
- Knowledge about national and EU legislation within the regulatory field.
- Ensure compliance with regulatory guidelines
Who we're looking for
- At least 5 years of professional experience within regulatory affairs.
- You have an knowledge of both the Belgian and European regulatory requirements and have the ability to interpret and apply regulations appropriately.
- You are a fast learner and is able to handle multiple tasks at the same time.
- Fluent in Dutch as well as English. Knowledge of French is a plus.
What you'll get
Our Pharma & Life Sciences department is growing. We offer you the opportunity to join our dynamic team of consultants, work on projects that will challenge you, and that will push you towards the next step of your career.