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الوصف الوظيفي المهارات The Labelling Lead Gulf & Levant is responsible to create and update the regional &/or country specific product information/PIL as well as the artworks related to the new product registrations and the maintenance of the registered products DRA Labeling Lead will be also responsible to create the BSS document for the whole portfolio to support the preparation of promotional materials for Gulf & Levant Prepare the planning/strategy for regional &/or country specific PIL/ packs artwork update for Gulf & Levant in coordination with the relevant internal and external stakeholders Prepare and coordinate the region &/or country specific packs update for Gulf & Levant in line with the approved and updated Product Information in the country of origin following a maintenance update or to reply to Health Authority specific request Maintain and update Product Information leaflets in region &/or country specific packs in line with the most updated and approved country of origin PIL due to Core Data Sheet Update, addition of a new indication, or any maintenance update that may impact the PIL text Initiate and coordinate the translations and column designs with third party suppliers for leaflet artwork preparation Coordinate with Medical Department for verification of translated product information leaflets Prepare the relevant comparison table for PIL update for Gulf & Levant, where relevant Responsible for the Track & Trace project/Data Matrix and Serialization (Artwork change) for the company’s portfolio Communicate and coordinate with local DRAs in Gulf & Levant the submission and approval of the updated PIL/ packs artworks Review and approve the artworks and ensure the correct distribution and use of the approved versions of artworks by the packaging sites Maintain an updated archive of the region &/or country specific packaging components on the DRA SharePoint Maintain and update a tracking record for the submissions and approvals of the updated PIL/packs artworks across the Gulf & Levant and properly communicate with the supply chain to ensure smooth product supply Develop and maintain good relationship with the DRA team in the Middle East Cluster as well as Global DRA/Labeling team Create and maintain an updated DRA BSS database for the whole active portfolio in Gulf & Levant in the DRA SharePoint Coordinate and share with the relevant stakeholders (Medical / Marketing) the most updated BSS to be used in the promotional materials Timely and accurate implementation of region &/or country specific packs/PIL Achievement of the compliance deliverables as per the Global targets when it is related to CDS/PIL/Pack update Product deliveries to the market according to the plans when it is related to PIL/CDS/Pack update (no stock out due to delay or non-compliance situation) Ensure 100% compliance of the promotional materials with the registered/approved PI Maintain a 100% updated BSS database Contribute to the effectiveness of DRA Department Accountable for maintaining product-related issues, which will ensure that products are available, as required Ensure compliance with Global commitment on product safety information Degree in Pharmacy (e.g. Pharmacy, Biotechnology, Pharmacology, Quality Assurance) or equivalent Excellent English is required (oral and written); Arabic is an advantage At least 3 years practical experience in Middle East Regulatory Affairs Knowledge of regulatory affairs and CMC documentation preparation Ability to critically evaluate data from a broad range of scientific disciplines Knowledge / experience of regulations, guidelines for product life cycle maintenance desirable Ability to work successfully with extended, multi-national project teams and coordinate activities simultaneously on multiple projects under pressure of time and workload Effective planning, organizational and interpersonal skills Excellent written / spoken interpersonal communication and negotiation skill تفاصيل الوظيفة https://www.bayt.com/ar/uae/jobs/labeling-lead-3890891/ |
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