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Regulatory Affairs Manager Nurofen/Biofreeze FR
Il y a 3 mois
"We are Reckitt"
Siège des marques d'hygiène, de santé et de nutrition les plus appréciées et les plus fiables au monde, notre objectif définit notre raison d'être : protéger, soigner et nourrir dans la quête perpétuelle d'un monde plus propre et plus sain. Reckitt, c'est avant tout une équipe de professionnels unis par cet objectif. Rejoignez-nous dans notre combat pour que l'accès à un monde plus propre et plus sain soit un droit et non un privilège L'équipe réglementaire FRBNL Au sein de l'équipe Affaires Réglementaires Health, le Regulatory Affairs Manager Nurofen/Biofreeze, rattaché au Senior Regulatory Affairs Manager du pôle OTC et chapeauté par le Directeur des Affaires Réglementaires FR-BNL, évolue dans une équipe de 12 personnes réparties sur 2 pays et agissant sur un périmètre cluster de 3 pays - France, Belgique et Pays-Bas. Vos missions En qualité de Regulatory Affairs Manager Nurofen/Biofreeze, vous aurez les missions suivantes :- Garantir la conformité réglementaire des produits et des processus et veiller à la qualité des produits mis sur le marché pour les gammes confiées notamment :
- Veiller au respect de la réglementation et à son application,
- Contribuer au maintien et à l'amélioration du système qualité en place,
- Veiller au respect des règles de publicité et de communication,
- Contribuer aux projets de développement (NPD et EPD) en apportant l'expertise réglementaire,
- Maintenir le portefeuille des AMM, coordonner les enregistrements nationaux et européens pour les étapes locales,
- Maintenir les bases de données à jour.
- Assurer la fonction de Deputy DSO
- Niveau Bac + 5 (Diplôme d'Etat, Docteur en Pharmacie)
- Une expérience significative de 5 ans dans un environnement en Affaires Réglementaires et en vigilance, dans le secteur pharmaceutique et avec une spécialité OTC
- Connaissance Pharmaceutiques : compétences scientifiques
- Connaissance des Affaires Réglementaires
- Connaissances médico-économiques
- Capacité d'organisation : gestion multi-tâches, respect des délais, respect des process.
- Rigueur, autonomie
- Sens du relationnel et esprit d'équipe
- Capacité d'adaptation
- Proactivité et anticipation
- Capacité de prise d'initiatives : challenge de statu quo, apport de solutions pour la résolution de problèmes
- Anglais courant
- Maîtrise parfaite de pack office
