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Job Details


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Job Details

Ihre Aufgaben

  • Provide support to complete product dossiers, technical files and responses to information requests required in order to market products internationally
  • Coordinate and complete documents required by federal agencies, maintaining complex files and electronic document management systems and work with project teams to obtain approval for company products
  • Execute tasks and exercise influence generally at the middle management level
  • In alignment with the overarching global regulatory strategy and in close collaboration with the Area and Affiliate Strategy regulatory team, this position serves as the primary interface with the affiliates to coordinate and complete international r
  • Serve as the primary point of contact with federal governmental agencies, embassies and consulates in Germany and center of excellence for requests related to all products with manufacturing licenses or that are released within the EU marketplace
  • Gather documents from all EU facilities required for product registration in applicable country/region
  • Coordinate document requests for products approved via the Centralized Procedure (CP) but are manufactured in Germany
  • Work directly with third party manufacturing companies to obtain documents

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