Labeling / Product Information Leaflet Lead - Pharma - Arabic Speaking

Job description / Role

Transguard workforce solutions have been engaged by our client to source an Arabic speaking 'Labeling Lead' for the Drug and Regulatory Affairs Department. Our client is a global pharmaceutical leader.

Please note that this role requires ability to speak and write Arabic fluently.

As a Labeling Lead based in Dubai, this role will be responsible to create and update the regional &/or country specific product information/Product Information Leaflet as well as the artworks related to the new product registrations and the maintenance of the registered products. Additionally to also support the preparation of promotional materials for Gulf & Levant. The scope of the responsibility will cover Gulf & Levant.

Requirements

Preference will be given to qualified candidates who can demonstrate experience in the following;
- To 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.
- To 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.
- To 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.
- To initiate and coordinate the translations and column designs with third party suppliers for leaflet artwork preparation.
- To coordinate with Medical Department for verification of translated product information leaflets.
- To prepare the relevant comparison table for PIL update for Gulf & Levant, where relevant.
- To be responsible for the Track & Trace project/Data Matrix and Serialization (Artwork change) for product portfolio.
- To communicate and coordinate with local DRAs in Gulf & Levant the submission and approval of the updated PIL/ packs artworks.
- To review and approve the artworks and ensure the correct distribution and use of the approved versions of artworks by the packaging sites.
- To maintain an updated archive of the region &/or country specific packaging components on the DRA SharePoint
- To 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.
- To develop and maintain good relationship with the DRA team in the Middle East Cluster as well as Global DRA/Labelling team.

BSS Database:
- To create and maintain an updated DRA BSS database for the whole active portfolio in Gulf & Levant in the DRA SharePoint
- To coordinate and share with the relevant stakeholders (Medical / Marketing) the most updated BSS to be used in the promotional materials.

The ideal candidate must hold a Degree in Pharmacy (e.g. Pharmacy, Biotechnology, Pharmacology, Quality Assurance) or equivalent and must have minimum 2 years' practical experience in Middle East Regulatory Affairs with excellent knowledge of regulatory affairs and CMC documentation preparation and desirable to have knowledge / experience of regulations, guidelines for product life cycle maintenance .

About the Company

Transguard Workforce Solutions delivers Professional Contract Staffing (also known as Employee Outsourcing) within the UAE.

Our Workforce Solutions include:

• Delivering Sourcing and Recruitment Solutions for Clients in need of identifying Contract or temporary Staff.

• Providing a complete end to end Staffing Solution which includes Visa Sponsorship, HR Management, Employee Welfare & Payroll Services.

• Transitioning Contract Staff from other staffing providers to Transguard while remaining compliant with UAE Labour and Immigration Laws.

Transguard Workforce Solutions currently employ over 2000+ Staff from over 70 different nationalities. Across the Group, we payroll over 70,000 employees monthly.