Regulatory Affairs Specialist

Il y a 6 mois


Le Havre, France Fresenius Medical Care Temps plein

Qualification:

- Diplôme scientifique/ Master en affaires réglementaires pharmaceutiques
- Bonne connaissance de la réglementation Marocaine/ Algérienne en termes d’enregistrement des produits Pharma et Dispositifs médicaux
- Bon niveau en anglais
- Expérience d’au moins un an en Affaires réglementaires
- Responsabilités:

- Assurer la veille réglementaire selon la procédure interne
- Évaluer les dossiers d'enregistrement, en veillant à la conformité du contenu des fichiers aux exigences réglementaires
- Traiter les demandes des autorités de santé en concertation avec le Pharmacien responsable et les partenaires
- Assurer la soumission et le suivi des différentes variations/déclarations, en coopération avec les principales parties prenantes
- Gérer les soumissions des nouveaux dossiers conformément aux réglementations locales en veillant à ce que les fichiers soient préparés et soumis à temps
- Assurer l’interaction avec les partenaires et la maison mère pour toute question liée aux affaires réglementaires
- Se déplacer au Ministère de la santé/DMP au besoin pour assurer les soumissions/ suivis des dossiers et la collecte des courriers



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