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