Regulatory Labelling Specialist Germany

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  • Progressive organisation
  • Full and Part-time opportunities
  • Excellent career opportunities
  • Generous salary and benefits

We are looking to identify a number of Regulatory Labelling Specialists for a global organisation based in Germany.  We require experienced regulatory professionals with some exposure and working knowledge of labelling as part of their varied skill set, and as we require a number of individuals, the roles are offered on a full or part-time basis. 

All roles are to be office based – Hesse Province

Key responsibilities:

  • Creation and provision of labelling texts for approval documentation
  • Responsible for the implementation of new and revised Company Core Data Sheets of products in regional / local product statements.
  • Search for country-specific regulatory requirements (D, EU) regarding content and structure as well as preparation of the data for coordination with the supervisor
  • Creation or adaptation of the structure in the GRDC and substructure in the electronic dossier
  • Compilation of Labelling-relevant documents or request for missing documents from the specialist departments, including deadline monitoring
  • Check the Labelling documents for plausibility, completeness and formal correctness
  • Creating or customizing summary explanations (explanation sheets, expert statements) in co-operation with the CCDS owner
  • Ensures compliance of product information, package leaflet, Labelling with regional / country specific regulatory and procedural requirements (ie general regulations, readability guidelines, regulatory templates, etc.).
  • Ensures that the regional / local packaging material is updated following Labelling changes
  • Shipping of the Labelling documentation (possibly in consultation with the approval groups) and provision of the Labelling texts according to country-specific requirements as well as electronic documentation of the incoming documents
  • Coordination of approvals - coordination and supervision of cross-departmental activities for the timely completion of the Labelling texts
  • Provision of regional / national Labelling texts and compilation of summaries for regional / local Periodic Safety Update Reports (PSURs) and promotional materials
  • Collaboration in global projects to implement and improve Labelling processes and systems.

Key requirements:

  • 4- 5 years professional experience within Regulatory Affairs
  • Some working experience within Labelling
  • Fluent German and English Language skills