Regulatory Affairs Officer

il y a 4 semaines

Greater Lyon Area, France Juvisé Pharmaceuticals Temps plein

L’entreprise


Juvisé Pharmaceuticals est une entreprise pharmaceutique dont la mission consiste à redonner la priorité à des médicaments essentiels afin d’améliorer la santé de millions de personnes à travers le monde.


Depuis notre création en 2008, notre portefeuille s’est constitué avec l’acquisition de médicaments « princeps » auprès de grandes entreprises pharmaceutiques. Nous nous concentrons sur des médicaments essentiels, reconnus par la communauté médicale pour leur valeur thérapeutique, et nous assurons leur production, leur commercialisation et leur promotion auprès des professionnels de santé. Ce faisant, nous contribuons chaque année à l’amélioration de la santé de plus de 2,5 millions de patients à travers le monde.


Juvisé Pharmaceuticals est aujourd’hui une entreprise reconnue internationalement, dont les médicaments en neurosciences, en gastro-entérologie, en oncologie, en cardiologie et en rhumatologie sont disponibles dans près de 80 pays dans le monde.


Bâtie sur un modèle décentralisé et performant, notre équipe concentre les fonctions clés à haute valeur ajoutée et s’appuie sur un solide réseau de partenaires externes.


Forts de notre stratégie d’entreprise et fidèles à notre ambition de répondre à des besoins médicaux encore non satisfaits, nous accélérons notre croissance en 2024 avec l’arrivée d’un médicament indiqué dans le traitement de la sclérose en plaques au sein de notre portefeuille.


Pour plus d'informations, veuillez visiter juvisepharmaceuticals.com


Le poste


Description du poste :


Juvisé Pharmaceuticals renforce son activité Regulatory Affairs Lifecycle. L’équipe Affaires Réglementaires est composée de 7 personnes réparties sur 3 domaines d’expertises : Intégration & Enregistrement, Lifecycle Management et Promotion. L’équipe s’appuie sur un réseau de partenaires locaux dans les différents pays avec des AMM actives et sur une plateforme de sous-traitance pour la consolidation des modules administratifs et le publishing.

Le Regulatory Affairs Officer viendra renforcer l’activité Lifecycle etaura pour mission d’accompagner les activités CMC, Safety et administratives permettant de maintenir la conformité réglementaire des AMM en vigueur et de l’établissement pharmaceutique.


Catégories des missions

Gestion du lifecycle réglementaire pour sa gamme de produits :

  • Organiser et planifier l’activité.
  • Apporter le support réglementaire aux services transverses, participer aux réunions projet.
  • Accompagner et déployer les stratégies réglementaires.
  • Maintenir les AMM : dossiers de variations, demandes de renouvellement, réponses aux questions des autorités de santé.
  • Coordonner et assurer le suivi des activités sous-traitées.
  • Assurer la vérification et la validation réglementaires des articles de conditionnement.


Participer aux activités transverses au sein de l’équipe :

  • Assurer la revue de la partie réglementaire des documents PV (exemples : PSUR, PEBR)
  • Participer aux activités de compliance réglementaire (CMC & CCDS)
  • Contribuer au suivi de la veille réglementaire


Compétences

  • Expérience dans les Affaires Réglementaires dans l’industrie du médicament (3 à 5 ans)
  • Rigueur et compétences organisationnelles
  • Curiosité / ouverture d’esprit
  • Proactivité, force de proposition
  • Agilité et capacité d’adaptation
  • Capacité à travailler en équipe
  • Sens du service et bon communicant(e)


Nous vous proposons


Salaire :

  • Une rémunération fixe versée sur 13 mois
  • Une prime pouvant atteindre 25%
  • Un dispositif de « Stock Equivalent »


Avantages sociaux :

  • 10 jours de repos offerts par an
  • Jusqu'à 2 jours par semaine de télétravail



Important : Ce document reprend les activités principales. Celles-ci ne sont pas exhaustives et peuvent évoluer en fonction des besoins de l’entreprise. D’autres activités peuvent être demandées au titulaire en fonction des besoins, sans pour autant modifier le descriptif. La polyvalence est exigée dans toutes les fonctions de l’entreprise.

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