Regulatory Affairs - Regional Dossier Publisher

Job description

Job Description The Regional Dossier Publisher (RDP) will work within the Global Regulatory Affairs and Clinical Safety (GRACS) organization, in the EU+EEMEA Regulatory Operations (RRO-EU+EEMEA) Team. The RDP is responsible for publishing key regulatory submissions in the region and supporting the publishing work carried out by our regional publishing team who are working on dossiers for the regions. The RDP will have a good knowledge of the regulatory procedures and dossier requirements in the regions and be able to apply this to the publishing processes and tools to ensure that the submissions delivered to the Country RA groups meet their specific needs. The RDP will also be involved with supporting Country RA teams with their local publishing and submission transmission needs and ensure they can meet their submission deadlines. The role will assist HQ Colleagues within RPP in the development of the tools and procedures that support our submission publishing procedures Primary Activities include but are not limited to: The RDP will be the regional expert for regulatory submission capabilities, including dossier structures and file formats, electronic submissions, and transmission...