SANOFI

Management produit

La vocation de Sanofi est d’accompagner celles et ceux confrontés à des difficultés de santé. Entreprise biopharmaceutique mondiale spécialisée dans la santé humaine, nous prévenons les maladies avec nos vaccins et proposons des traitements innovants. Nous accompagnons tant ceux qui sont atteints de maladies rares, que les millions de personnes souffrant d’une maladie chronique. Sanofi et ses plus de 100 000 collaborateurs dans 100 pays transforment l’innovation scientifique en solutions de santé partout dans le monde. Sanofi, Empowering Life, donner toute sa force à la vie. Chez Sanofi, la diversité et l’inclusion sont au cœur de notre fonctionnement et sont intégrées à nos Valeurs fondamentales. Nous sommes conscients que pour exploiter véritablement la richesse que la diversité nous apporte, nous devons faire preuve d’inclusion et créer un environnement de travail où ces différences peuvent s’épanouir et être développées pour améliorer le quotidien de nos collègues, patients et clients. Nous respectons et valorisons la diversité de nos collaborateurs, leurs parcours et leurs expériences dans un objectif d’égalité des chances pour tous.

Le contenu de ce poste est libellé en anglais car il nécessite de nombreuses interactions à l'international, l'anglais étant la langue de travail. As part of the stand-alone project of the CHC Business unit process, this role is to be transferred within the Opella Healthcare Group Legal Entity. The Regulatory Affairs CHC Regional Coordinator is responsible for managing of portfolio of regional products under development and/or marketed products. For multi-regional products/projects the Regional coordinator provides support to Global CHC Regulatory Categories as appropriate for some operational aspects on dossiers preparation and submission. Specific requirements and responsibilities include: Develop regulatory strategy and provide regulatory expertise within project/product teams for products under development and/or marketed productsDefine, coordinate and contribute to the preparation of the dossiers and responses document to Health Authority questions with the stakeholders (Non clinical, clinical, Medical, Pharmacovigilance, etc.)Accountable for the maintenance of the existing INT CHC portfolio, managing the maintenance activities such as renewals, variations, SEP update, benefit/risk assessments, referrals, discontinuation process, PBRER/PSUSA/DSUR, etc.Ensure compliance of  regulatory activities for  development and  marketed productsCoordinate Regulatory sub-teams within GRA and be the regulatory representative in outside GRA multi-function teams: Sample, Reference standard, CMCProvide regulatory support for registration activities in countries outside the RegionLead and coordinate scientific advices (including briefing package preparation), oral explanations and pre-submission meetings for Regional projects/productsEnsure regulatory database and regulatory requirements are updated : VEEVA, STARR, VISTA,  Contribute as needed to review the opportunities from Business Development COMPETENCIES Education: Physician, Pharmacist, Veterinarian or Life Sciences Degree,Comprehensive knowledge and operational expertise of Regional regulationsCHC portfolio knowledgeRegulatory and supply chain Databases knowledgeAbility to work with multifunctional and multicultural teamsAbility to produce written and oral regulatory or scientific communications with clarity, accuracy and rigorAbility to communicate effectively and efficiently with other functional departments in the businessGood relationship abilityAbility to think strategically and strive for resultsAbility to make decisionsAbility to resolve issues and proactivityFluent English EXPERIENCE 3-5 year experience in the CHC or pharmaceutical industry, in Regulatory Affairs (global, regional or local)Project management experience in the pharmaceutical industry or in a regulatory environment.Demonstrated ability to work in a matrix environment and implement operational regulatory excellenceFluent in French and English