
- Professional
- Escritório em Airoli
Job Description
- Preparation of dossiers for Europe, Australia, New Zealand, and Canada (EANC). - Responding to queries from regulatory agencies of EANC advanced markets and customers. - Liaising with R&D, manufacturing plants, clinical teams, and respective EANC offices/BD teams. - Assisting in the life cycle management of EANC-registered products by obtaining variation approvals. - Maintenance of departmental databases. - Regular study of regulatory guidelines and electronic Common Technical Document (eCTD).