Senior Regulatory affairs specialist job in Paris, Île-de-France

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This vacancy has now expired. Please see similar roles below...

Senior Regulatory Affairs Specialist
Ile de France - CDI
Description:

Prépare les dossiers de variations (CMC et labeling) en lien avec l'ERMC et l'international
Suivi des dossiers auprès des autorités de santé
Activité d'implémentation des modifications AMM
Traductions des annexes
Contrôles des BAT des articles de conditionnement
Assurer la bonne qualification des documents de communication transmis par les équipes internes et assurer leur conformité réglementaire
Veiller les changements de réglementation, de pratiques promotionnelles, les sanctions éventuelles, et évaluer leur impact sur les activités associées.
Assurer le dépôt des dossiers de publicité, leur suivi et leur archivage

Profil:

Anglais Fluent ( appels entrants/TC)
5 à 6 ans d'expérience minimum
Diplôme Pharmacien

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Sarah Fenanir on +33 184 886 626 or upload your CV on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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