For one of our client located in the Walloon Brabant, we are looking for an enthusiastic and experienced Regulatory Affairs Assistant Belgium and Luxembourg.
- Do you have a Baccalaureate (“graduate”) level?
- Do you have experience in working in the Regulatory Affairs environment ?
- Do you have a good level of spoken and written English and French?
If this applies to you, don't hesitate to contact us and/or send your CV!
As Regulatory Affairs Assistant you will be responsible for preparing and submitting regulatory dossiers (initial marketing authorisations applications, variations, commitments, PSURs, answers to questions, renewals,..) to the Belgian Federal Agency for Health and Medicinal Products and to the Luxemburgish Ministry of Health in accordance with the legislation. You will be also responsible for following up with these Regulatory Authorities up to the approval.
The timely approval of changes are key to ensure continuity of vaccine supply, not only on the Belgian and Luxembourg markets, but also on all markets outside Europe relying on the Belgian (source-country) regulatory approvals.
- In line with legal requirements, you prepare the submissions of regulatory dossiers specific to Belgium and Luxembourg based on the generic data packages provided by the Regulatory Affairs Project teams.
- You ensure that regulatory dossiers are submitted in due time to the Belgian and Luxemburgish Regulatory Authorities via the Common European Submission Platform, and are successfully validated.
- You ensure that the financial obligations relative to each submission are met.
- You are responsible for handling the administrative steps to allow final administrative approval of variations and renewals leading to the issuing of updated marketing authorisations.
- You are responsible for internal communication of regulatory approvals and appropriate tracking in databases.
- You ensure that the official communications with the Regulatory Authorities and the updated marketing authorisation are stored in appropriate databases.
- You communicate with the Belgian and Luxemburgish Regulatory Authorities as appropriate, as well as with Project teams and with the Local Operating Company developing the Prescribing Information artworks for vaccines.
- You have a baccalaureate (“graduate”) level.
Knowledge / Experience :
- You have experience in working in the Regulatory Affairs environment (asset).
- You have a similar experience in working with the Belgian and Luxemburgish Regulatory Authorities (asset).
- You have a good level of spoken and written English and French.
- You are able to develop relationships based upon trust and mutual respect.
- You have excellent organizational and planning skills to meet agreed short-term deadlines.
- You are flexible and you have the sense of urgency.
- You are analytical and detail oriented.
- You can use databases.
- You are customer oriented and a good team player.
- You are autonomous.
- You have good communication skills.
- You are fluent in English and in French (oral and written).
+32 2 588 16 07