Associate Director Regulatory Affairs

4 weeks ago

Montréal QC, Canada St-Amour Full time

Nous avons présentement un poste de Directeur(trice) Associé(e) - Affaires Réglementaires avec une pharmaceutique internationale. Vos responsabilités incluront la préparation, la compilation, la rédaction et la révision des dossiers d'enregistrement internationaux, ainsi que la gestion du dépôt, du suivi et de l'approbation des documents réglementaires.Ce rôle implique la gestion du département des affaires réglementaires, l'alignement des stratégies réglementaires avec les objectifs de l'entreprise, et la supervision des activités réglementaires mondiales relatives à la CMC. Il comprend l'élaboration de stratégies pour les projets pré-approbation, la réalisation d'analyses de lacunes et l'assurance de la conformité. Vous serez responsable de gèrer les modifications post-approbation, maintenir la communication avec les agences réglementaires, répondre aux demandes d'information et assurer la conformité avec les réglementations internationales. Vous gèrerez les mises à jour périodiques de sécurité, supervisez le personnel, collaborez avec les équipes interfonctionnelles, allouerez les ressources et préparez les budgets.

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