Irina Maier

Berufserfahrung von Irina Maier

• Bis heute 12 Jahre, seit Juli 2012

  Specialist Regulatory Submissions New Products

  STADA Arzneimittel AG

  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

• 5 Jahre und 3 Monate, Mai 2007 - Juli 2012

  Technical Assistant Regulatory Affairs

  STADA Arzneimittel AG

  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.