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Responsable Liaison Réglementation Internationale
3 months ago
Gilead Sciences International, Ltd. recherche un expert en réglementation pour diriger des projets complexes et stratégiques dans le domaine biopharmaceutique.
En tant que Responsable Liaison Réglementation Internationale, vous jouerez un rôle clé en définissant les stratégies réglementaires et en supervisant les équipes de soumission réglementaire. Vous travaillerez en étroite collaboration avec les autorités réglementaires pour obtenir et maintenir les autorisations nécessaires, tout en optimisant les placements sur les formulaires.
Vos responsabilités incluent :
- Superviser les activités réglementaires pour une gamme de produits dans un domaine thérapeutique défini.
- Participer aux négociations avec les autorités réglementaires et contribuer au développement et à l'amélioration des stratégies réglementaires.
- Diriger la stratégie réglementaire pour plusieurs produits, en identifiant proactivement les risques réglementaires et en développant des plans d'atténuation.
- Superviser les soumissions réglementaires et l'approbation de documents, tout en contribuant à l'amélioration continue des capacités de Regulatory Affairs.
Profil recherché :
Vous possédez une expérience étendue dans l'industrie biopharmaceutique avec une expertise en réglementation et une capacité avérée à gérer des projets complexes et multigénérationnels. Vous avez une forte présence en leadership, la capacité d'influencer et de travailler avec des équipes multidisciplinaires.
