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METAP Labelling Coordinator Specialist
À propos de l’offre d’emploi
Overall scope consists of providing support to Regulatory Affiliate in oversight of all related labelling activities, primarily in:
- Coordination of submission planning, preparation, review of new or modified labeling texts for METAP shared packs and country specific packs in collaboration with affiliates.
- Liaison with internal departments and external partners (Third Party Manufacturers) to collect needed information enabling labelling preparation & maintenance in compliance with local market requirements.
- Create & share Updated labels ready for submission package with local affiliate to comply with the latest approved labeling product information.
- Manage and coordinate local language translations of PIL/labels as applicable.
- Coordinate the workflow of the label change for local & regional labeling using validated tools & systems including proofreading.
- Coordinate in collaboration with local affiliates the review and approval from regulatory, Medical and marketing as applicable.
- Track, follow-up and communicate implementation with support of SupplyChain and Quality
- Manage, track and maintain approved labeling materials archives and database.
- Ensure that changes/new creations are approved and implemented on time to meet HA commitments and internal compliance guidelines while maintaining uninterrupted and optimized supply for operations.
- Create and maintain local procedures & documents as needed.
- Act as subject matter expert for labeling related activities and procedures and perform regular training as needed.
- Identify labeling issues (as errors, inconsistencies and conflicts) between package leaflet and SmPC and take the lead to solve such issues.
- Perform any other duties as requested by the management.
- Optimize the use of the company resources while fulfilling the above activities.
- Support in PharmacoVigilance Local & Regional Audits preparation & execution as applicable
- Ensure record retention (archiving)
1. Planning & Compliance Tracking
- Track & Maintain labelling history files and old versions of labels by retaining most current versions of Packaging/Prescribing Information Labels.
2. Stakeholders Coordination
- Maintain working relationships with defined countries and provides timely and high-quality support as per internal procedure.
3. 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 letter…etc)
- 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.
4. Coordinate the WorkFlow of Mock ups & LCR request
- In line with Global / regional/local procedures and validated tools & System.
5. 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.
. apply . 
