Chef de projet Affaire Règlementaire et Digital
Gentilly, France Regular Posted on Aug. 06, 2025 Closing on Dec. 06, 2025Cette offre d’emploi est ouverte à toutes et tous, quel que soit le genre auquel s’identifie le candidat ou la candidate.
Intitulédu poste :Chef de projet Affaire Règlementaire et Digital
Location : Gentilly (France)
À propos du poste
Our Team :
Fin 2023, Sanofi a ouvert un nouveau chapitre de sa stratégie Play to Win centrée sur la science avec l’ambition de devenir le leader mondial de l’immunologie, et ainsi changer la vie des patients.
Les priorités de GRA, contributeur clé de la performance de Sanofi, sont définies autour de 4 piliers : un partenaire stratégique avec les agences de santé, une organisation efficiente, une organisation axée sur la donnée et le digital, le développement des collaborateurs.
Par ailleurs dans un contexte de Digitalisation le rôle des Affaires Réglementaires est en perpétuel évolution. Afin de devenir un Professionnel Bionic, il est important que la Direction des Affaires Réglementaires (DAR) France de Sanofi Winthrop Industrie (SWI) site exploitant, s’équipe afin d’être un acteur principal de la transformation digitale.
Dans un contexte dynamique de nouveaux lancements et de digitalisation, le Responsable Produit BU Médecine de Spécialités et projets spéciaux digitaux est responsable de mettre en œuvre toutes les activités nécessaires pour accélérer la digitalisation des activités de promotion des nouveaux produits des BU Médecine de Spécialité en supportant au besoin les autres BU de la DAR et de travailler en étroite collaboration avec l’équipe transverse et les autres BU afin d’assurer la démocratisation de la donnée et des nouveaux outils de GenAI.
Main responsibilities :
Promouvoir l’utilisation de GenAI dans le contexte de validation du matériel promotionnel tout en participant aux pilotes mis en place au sein du département
Proposer des simplifications de process au niveau local afin de les rendre plus efficace grâce à l’utilisation des outils digitaux
Supporter l’équipe avec le support de l’équipe transverse dans sa transformation digitale
Gérer le portefeuille produit dont il a la charge sur la BU Médecine de Spécialité :
Activité d’enregistrement – suivi des activités avec le Global notamment pour les procédures centralisées permettant l’intégration des exigences nationales aux stratégies globales. Assure les traductions des Annexes de l’AMM, ainsi que les demandes de Blue Box et code CIP pour les procédures centralisées
Implémente et valide les changements dans les documents informations produits / maquettes, tout en assurant la diffusion en interne et mise en ligne sur les bases de données
Assure la traçabilité et l’archivage dans les bases de données réglementaires
Participe à l’élaboration des Mesures Additionnelles de Reduction des risques en collaboration avec la Pharmacovigilance
Gère les interfaces avec ANSM et organise les réunions de concertations ou de conseil scientifique
Participe à l’élaboration du plan de développement et Business Plan des produits de la BU en collaboration avec les différents départements impliqués (médical, marketing, accès au marché, Global)
Garantit la conformité des documents promotionnels avec les référentiels en vigueur et interagit avec ANSM en analysant et diffusant les refus de visas tout en proposant une stratégie en conséquence pour la BU et ANSM
Participe aux audits et inspections
Assure une veille réglementaire sur l’ensemble des activités relevant de sa responsabilité et partage les informations avec l’ensemble de l’équipe et partenaires
À propos de vous
Experience :
Votre expérience démontre une expertise dans la gestion de projets à fort enjeux ainsi qu’une expérience dans la démocratisation de la donnée et du digital. Une bonne connaissance de la Réglementation Française / Européenne dans le médicament mais également dans le digital et la promotion
Soft skills :
Faire preuve d’agilité, de proactivité et de prise d’initiative
Appétence pour le Digital et le développement de l’intelligence Artificielle
Avoir la capacité de se remettre en question permanente et d’appréhender une approche TRT au quotidien
Communiquer de façon convaincante et influente
Travailler en équipe et en transversalité avec les autres équipes de la DAR / GRA (ONE DAR / GRA) et autres fonctions partenaires
Être orienté résultats
Avoir un esprit d’équipe positif
Technical skills :
Connaissance de la Réglementation Française et EU ainsi que scientifique / promotionnel et digital / maîtrise des outils et Base de données / Digital / Intelligence Artificielle
Education :
Pharmacien avec une spécialisation en Affaires Réglementaires
Languages :
Français – Anglais Bilingue
Toujours progresser.Découvrirl’extraordinaire
Rejoignez Sanofi et entrez dans une nouvelle ère de la science – où votre parcours peut être aussi transformateur que le travail que nous accomplissons. Nous investissons en vous pour que vous alliez plus loin, accélériez votre réflexion et accomplissiez ce qui n’a jamais été fait auparavant. Vous contribuerez à repousser les limites, à bousculer les conventions et à concevoir des solutions plus intelligentes pour les communautés que nous servons. Prêt·e à poursuivre les miracles de la science et à améliorer la vie des gens ? Poursuivons le progrès et découvrons l’extraordinaire – ensemble.
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Join Sanofi and step into a new era of science - where your growth can be just as transformative as the work we do. We invest in you to reach further, think faster, and do what’s never-been-done-before. You’ll help push boundaries, challenge convention, and build smarter solutions that reach the communities we serve. Ready to chase the miracles of science and improve people’s lives? Let’s Pursue Progress and Discover Extraordinary – together.
At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, protected veteran status or other characteristics protected by law.
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