Regulatory Affairs Responsible
Neuilly-sur-Seine, France Permanent Posted on Mar. 18, 2025 Closing on Jun. 17, 2025Opella, la division Santé Grand Public de Sanofi, est le troisième acteur mondial du marché de la santé Grand Public -médicaments en vente libre, vitamines et compléments alimentaires.
Nous sommes convaincus qu’aider plus d’un demi-milliard de patients et de consommateurs à travers le monde à prendre leur santé en main est essentiel pour bâtir un monde et une planète plus sains, pour tous.
C’est pourquoi, notre mission est de rendre la santé aussi simple qu'elle devrait l'être, grâce à des solutions du quotidien, inspirées par nos consommateurs et fondées sur la science.
Cette mission est portée par nos 100 marques phares, dont 15 marques mondiales et locales à forte croissance telles que Allegra, Dulcolax et Buscopan, et par l’engagement de nos 11 000 collaborateurs et collaboratrices dans le monde, répartis sur 13 sites de production et 4 centres de recherches et développement.
Nous sommes également fiers d'être la première entreprise de santé grand public d’envergure mondiale à avoir obtenu la certification B Corp.
Missions:
Réaliser et suivre les actions réglementaires relatives au Module 3.2.S dans le cadre des activités internes: projets d'extensions géographiques, qualifications de nouveaux fournisseurs, maintenances de dossiers
Participer à l'évaluation et à la mise en place des changements notifiés par les fournisseurs
Gérer les demandes réglementaires des clients
Participer à la rédaction des procédures dans le cadre de la création du service
Apporter l'expertise réglementaire lors de projets multi-métiers
Activités principales: participation active aux réunions projet, organisation des CCC, évaluation des changements, évaluation et revue de la documentation liée aux projets, mise à jour des dossiers réglementaires et suivi des soumissions, rédaction des procédures
Profils:
Diplôme en Chimie ou en Pharmacie ou expérience de 3 ans minimum en Affaires Réglementaires dans le domaine de l’industrie pharmaceutique
Master en Affaires Réglementaires
Expériences en rédaction CMC (Module 3)
Connaissances en Assurance Qualité opérationnelle (audits fournisseurs, réclamations, déviations, CAPAs, gestion des changements)
Anglais professionnel écrit et parlé
Qualités organisationnelles, rigueur, force de proposition
nullPursue progress. Discover extraordinary.
Progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let’s pursue progress. And let’s 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, or gender identity.
Watch 'One day at Sanofi' and check out our Diversity Equity and Inclusion initiatives at sanofi.com
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Sanofi careers in France
We're 20,000 people, working across 28 sites in France with one goal: getting medicines and vaccines to people who need them most. From day one, you'll take on exciting projects to set the course of your career. Whether you're a researcher or a marketer, you'll discover the tools, resources, and support you need to pursue progress. Develop your skills and work in inclusive teams to positively impact millions of people globally.
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