METAP Labelling Specialist

2 weeks ago


Cairo, Cairo, Egypt Abbott Healthcare Full time

  • Planning & Compliance Tracking

Track and maintain labelling history files and old versions of labels by retaining most current versions of Packaging/Prescribing Information Labels.


  • Stakeholders Coordination
Maintain working relationships with defined countries and provides timely and high-quality support as per internal procedure.

  • Submission Execution and Compilation
Advise Business Partners (Portfolio Expansion Lead, Global Labelling Group) on MEAP local regulatory requirements. Identify/obtain required documentation and ensure content meets requirements for the registration of labelling changes. Manage the preparation of registration packages and coordinate additional requests related to deficiency letters, safety-related inquiries and label deviations. Manage the preparation of the comparative table as needed. Prepare easy to read English text, coordinate translation and proof-reading for updated/translated labels. Follow-up on documentation availability (CPP, Ref.

country approval ) Ensure internal approval for the complete submission dossier (Affiliates' sign-off) prior to filing Dispatch and archive submission dossiers Coordinate labeling update submissions with regulatory affiliates and follow-up on approval.


  • Coordinate the Workflow of Mockups & LCR request
In line with global/regional/local procedures and validated tools & System.

  • Regulatory Intelligence & Process Improvement
Identify and recommend opportunities for improvement to the labelling processes, quality, systems, tools and policies. Benchmark existing processes against external processes. Implement process improvements. Regularly monitor, assess, interpret new local regulations related to labelling activities and communicate impact accordingly. Maintain regional labelling procedures up to date.

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