METAP Labelling Specialist

• 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 Supply Chain 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)

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

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

• 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.

• 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.

• Precision and accuracy in task execution
• Flexibility
• Assiduity and hard working
• Ability to manage multiple projects at the same time and deliver results within deadlines
• Ability to work under pressures and deadlines
• Critical thinking and ability to challenge the status quo
• Strong communication skills
• Detail-oriented

• Chemistry, Biochemistry, Pharmacy
• Years of experience: 1-5 years (Regulatory, Labelling, Supply chain)

• Minimum 3 years of relevant experience in Labelling
• Knowledge of labelling requirements procedures, policies and standards
• Strong commitment to compliance with the relevant rules and procedures, and to scientific quality and integrity
• Regional experience is highly recommended.
• Detail-oriented, communication, compliance and process Improvement skills.
• Proficiency in English language
• Computer Knowledge: Knowledge of Agile system & the Office package (Ms Word, Ms Excel, Ms Power Point)

Abbott