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Your main tasks:

  • 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“

Your profile:

  • 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)
  • Organized with good communication skills
  • Willing to travel internationally
  • Team work skills
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