JOB DESCRIPTION:
Job Title
Regional Labelling Specialist
About Abbott
Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.
Working at Abbott
At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You will have access to:
Career development with an international company where you can grow the career you dream of. A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune. A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.
The Opportunity
This position works out of our Egypt affiliate in the Established Pharmaceutical Division where we are committed to bringing the benefits of our trusted medicines to more people in the world’s fastest-growing countries. Our broad portfolio of high-quality and differentiated branded generic medicines reaches across multiple therapeutic areas including gastroenterology, women's health, cardiometabolic, pain management/central nervous system, and respiratory.
As the METAP labelling specialist, you’ll have the chance to handle different labelling projects, working closely with cross-functional teams. You’ll manage labelling, artworks, implementation progress and updates end to end for the product porfolio.
What You’ll Do:
Support managing labelling activities within Egypt and Saudi coverage areas to ensure activities are completed consistently in a timely manner in accordance with internal processes and local and international regulatory requirements. 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 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).
1. Planning & Compliance Tracking
Track and 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 Mockups & 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.
Required Qualifications
Chemistry, Biochemistry, Pharmacy Degree Years of experience: 1-5 years (Regulatory, Labelling, Supply chain) 1-2 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 beyond Egypt is highly recommended. Detail-oriented, communication, compliance and process Improvement skills. Proficiency in English & Arabic languages; French is highly recommended. Computer Knowledge: Knowledge of Agile system & the Office package (Ms Word, Ms Excel, Ms Power Point)
Preferred Qualifications
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
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.
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The base pay for this position is
N/AIn specific locations, the pay range may vary from the range posted.
JOB FAMILY:
Regulatory Operations
DIVISION:
EPD Established Pharma
LOCATION:
Egypt > Cairo : KTC Building
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
Not specified
MEDICAL SURVEILLANCE:
Not Applicable
SIGNIFICANT WORK ACTIVITIES:
Not Applicable
