Irina Maier

Planning and realisation of new product submissions in the EEA. Preparation of dossiers by means of electronic systems (Document Management Systems/Publishing) Key User for Register Database: Collaboration with Regulatory Operations department as representative of Regulatory Affairs for regulatory-dependent processes. Preparation of SOPs and user instructions

Support in preparation of new product submissions and maintenance activities of approved products in the EEA. Responsible for preparation of applications by means of electronic systems (Document Management Systems/Publishing) for submission to marketing Authorities in the EEA. Entries and updates of Database. Logistic support. Key User for Database: Participation in meetings after "go-life” of database. Preparation of SOPs and user instructions.