Global Regulatory Affairs Coordinator - VIE Contract (W/M) > Joboolo BE :
Société : Sanofi Lieu : Ghent Flanders Site source : Talent BE
At Sanofi diversity and inclusion is foundational to how we operate and is embedded in our Core Values.
We respect the diversity of our people, their backgrounds and experiences.
We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our employees, patients and customers.We are looking for:
GlobalRegulatoryAffairsCoordinator - VIE Contract (W/M)Target start date:
01/04/2024Responsibilities:
Support the GRL for the meetings of the product regulatory team composed of the different regulatory experts (RegCMC, RegLabeling, Regional Regulatory contacts, Regulatory Operations):
preparation, meeting minutes, follow-up of actions includingDevelop the document summarizing the GlobalRegulatory Product Strategy (GRPS)Assist in management and conduct of the Globalregulatory activities for assigned projects in line with regulatory requirements.
Preparing, compiling, reviewing and processing the regulatory submissions including both pre-approval and submissions amendments/supplements, annual & study reports, investigator brochures, etc.Support the compilation, development, submission, and maintenance of worldwide regulatory filingsTrack regulatory project status and informational documentsCoordinate required documentation in coordination with partners or Functional groupsSupport operational and compliance activities for assigned deliverables, develop, execute and maintain including generating submission content plans, submission tracking, and document management utilizing the support and input of cross-functional team and/or alliance partners where relevantRequirements:
Master of Science in RegulatoryAffairsExperience preferably in RegulatoryAffairsGood communication, coordination / facilitation and relational skillsProficient in English written and oral communication skillsSolid knowledge of MS Office softwareAbility to have a rapid and solid expertise in electronic document management systems (e.g.
Veeva vault, Plai)Organisation skills, entrepreneurialFlexibility, creativity & enthusiasmMotivated and open-minded, able to work in a team and interacting on cross-cutting and multicultural subjectsAt Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values.
We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers.
We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all. Sanofi GhentFlanders
