Preparation and planning of variation notifications based on the Change Control System in Document Management System in co-operation with the Global Regulatory Affairs departments.
Evaluation of impact of changes in relation to international registration status in co-operation with international local Regulatory Affairs Departments and documentation in corresponding databases & tools.
Preparation of respective documentation to support change notifications at competent authorities and local Regulatory Affairs organizations.
Tracking and update of international registration status with respective tools and databases.
Tracking of regulations in countries from aria of responsibility
Registration of new products and execution of re-registrations in international countries in co-operation with the Global Regulatory Affairs Department.
Update labelling requirements and support for labelling updates according to the identified requirements.
Preparation of documentation for customer specific request (tender etc.) in co-operation with Global Regulatory Affairs
Maintenance of regulatory documentation
Preparation of declarations in co-operation with Global Regulatory Affairs
Supports task forces and specific Regulatory Affairs related projects
Assure lessons-learned procedures
Safeguarding/Adherence of Compliance Regulation “Code of Conduct“
University degree in pharmacy, chemistry, biochemistry, biology, medicine, bioengineering, or medical engineering,
Fluency in English (written and verbal); German is an advantage,
Good computer skills (MS Office, Adobe Professional, Outlook, SAP is an advantage)