Regulatory Labelling Specialist Germany

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

Contact: Neil Dewsbury
Email: neil.dewsbury@zestbusinessgroup.com
Telephone: 0114 238 1728