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Senior Regulatory Affairs Manager H/F
Il y a 4 mois
Quelles sont les missions ?
Pharmélis, cabinet de recrutement et organisme de formation, spécialiste des postes cadres, d'experts et de dirigeants, partenaire depuis plus de 18 ans des entreprises du secteur Santé (Pharmaceutique, Cosmétique, Dispositifs Médicaux, Biotechnologie...), accompagne son client, laboratoire pharmaceutique d'envergure internationale, dans le recrutement d'un Senior Regulatory Manager.
Membre du département des Affaires Réglementaires au niveau Européen et rattaché(e) au Directeur des Affaires Règlementaires France /PR, vous fournissez des informations, des conseils et un soutien en matière de réglementation à l'Europe (divisions du développement et commerciales) selon les besoins.
Ainsi, vos missions seront :
- Soutenir le leadership et la gestion des activités stratégiques et opérationnelles de la fonction des affaires réglementaires Europe.
- Assurer l'approbation par les autorités réglementaires des programmes d'utilisation compassionnelle et/ou d'autres programmes d'accès précoce pour les produits (pas encore) approuvés.
- Fournir une expertise en matière d'affaires réglementaires aux équipes de marque (par exemple, recueillir les commentaires stratégiques des équipes locales sur les premières ébauches d'informations sur les produits nouveaux ou révisés).
- Définir et mettre en oeuvre des stratégies réglementaires européennes ou mondiales pour les projets, en se concentrant particulièrement sur le développement précoce jusqu'à la preuve de concept clinique.
- Contribuer à la mondialisation de l'organisation en travaillant en étroite collaboration avec des collègues d'autres pays afin d'harmoniser et d'adopter les meilleures pratiques.
- Dans le cadre de ces responsabilités, veiller à ce que les bonnes pratiques (GXP) soient adoptées et mises en oeuvre à l'Europe.
- Etre Responsable des activités CMC (chimie, fabrication et contrôles) du produit mis sur le marché, en particulier :
Gère la procédure de reconnaissance mutuelle européenne ;
Établir la stratégie réglementaire pour les changements administratifs, les qualités, la sécurité, l'efficacité et la pharmacovigilance ;
Effectue l'évaluation réglementaire des demandes de changement ;
Participe à la gestion des événements liés à la qualité (déviations, plaintes relatives à la qualité des produits, changements, ruptures de stock, rappels de lots) ;
Participer aux audits/inspections et à leur suivi ;
Quel est le profil idéal ?
Vous êtes pharmacien, idéalement mais pas obligatoirement inscriptible PRI, avec une spécialité dans les affaires réglementaires.
Vous possédez une expérience significative des affaires réglementaires européennes acquise dans l'industrie pharmaceutique, y compris une expérience de la gestion, du maintien et de la conformité des phases I et II des essais cliniques et du développement précoce à l'échelle européenne.
Vous avez une parfaite compréhension du processus de développement des médicaments et de la place et de la manière dont les aspects réglementaires s'y intègrent.
Qui a publié cette offre ?
Pharmelis - Cabinet de recrutement et organisme de formation -
Life Sciences
84 avenue du Maine 75015 paris
