Regulatory Affairs Officer

il y a 1 mois


Paris, France BTG Specialty Pharmaceuticals Temps plein

Venez sauver des vies avec nous

Notre laboratoire pharmaceutique international est un allié dévoué des prestataires de soins de santé, qui traite des patients souffrant de maladies critiques, en se concentrant sur les traitements d'urgence et les maladies rares. En plein développement, nous comptons actuellement plus de 400 employés dans 10 pays, pour 300 m€ de chiffre d’affaire.

Notre portefeuille de plus de 80 médicaments et traitements d'urgence impacte véritablement la vie des patients et de leurs soignants, ce qui donne à chacun de nos collaborateurs un sentiment d'utilité en contribuant à cette cause.

**Notre objectif est soutenu par nos 4 valeurs clés**:
Nous faisons des patients notre priorité
Nous agissons avec intégrité et responsabilité
Nous travaillons ensemble comme une seule équipe
Nous cherchons en continu de meilleures façons d'avancer

Mission générale

Le chargé d’affaires réglementaires gérera les aspects réglementaires des projets et de produits destinés à faire l’objet de demandes d'autorisation de mise sur le marché (AMM) et sera responsable de la préparation et maintenance de la documentation du dossier réglementaire (y compris les aspects CMC et l’Information Produit) en Europe ou dans le monde pour les projets/produits assignés.

En tant que Chargé des Affaires Réglementaires, vos responsabilités incluront:
Mettre en œuvre les stratégies réglementaires pour l'enregistrement et la maintenance d’un portefeuille de produits ou des projets en Europe ou dans le monde, via la gestion du cycle de vie des produits assignés.
Assurer l’interface avec les autorités réglementaires pour les produits assignés
Coordonner les activités réglementaires avec les représentants locaux pour les produits assignés
Gérer les partenaires réglementaires pour identifier et proposer le support réglementaire approprié pour chaque projet
Assurer l’interface avec les parties prenantes internes (Médical/Pharmacovigilance/Qualité /Approvisionnement) et externes (site de fabrication, sous-traitants) pour assurer la mise à disposition des livrables en temps voulu
Revoir et valider le matériel promotionnel conformément à la réglementation en vigueur pour les produits assignés
Participer à la Veille Réglementaire afin d’identifier et communiquer les implications des développements à venir avec les parties prenantes en interne
Participer aux activités d'information médicale (support réglementaire aux demandes et préparation de FAQ) pour les produits assignés
Participer à l'élaboration et à la mise à jour des procédures et processus réglementaires de l'entreprise

**Pour réussir dans le poste**:
Pharmacien ou diplôme scientifique équivalent avec Master en affaires réglementaires
3 à 5 ans d'expérience dans un rôle d'Affaires Réglementaires dans un environnement international, idéalement avec une expérience dans la rédaction/révision d'AMM et la gestion du cycle de vie.
Capacité à établir et maintenir des relations de travail efficaces avec les intervenants internes et externes.
Solides compétences en communication écrite et verbale.
Anglais courant.

**Contrat**:
CDI à temps plein à pourvoir immédiatement - Paris 8e arrondissement

S erb Pharmaceuticals is an equal opportunity employer. We offer competitive compensation & benefit packages, challenging opportunities and a culture of working together in a supportive way built on our strong foundation of values.



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