Summary The RA-GDD Senior Labeling associate Gulf & Levant is responsible to create and update the regional product information (RO2)/PIL as well as the artworks related to the new product registrations and the maintenance of the registered products. The scope of the responsibility will cover Gulf & Levant. RA-GDD Senior Labelling associate will be also responsible to create the NSS document for the whole portfolio to support the preparation of promotional materials for Gulf & Levant. Major accountabilities:Labelling Project - PIL / packs Artwork update for Gulf / Levant

• Ensure early engagement with global teams, countries and labeling team to align on the submission strategy for NDAs, new indication, line extension and any other LCM activity affecting labeling.
• Prepare and coordinate the region- specific packs update for Gulf & Levant in line with the approved and updated US/ EU/ Swiss Product Information following a maintenance update or to reply to Health Authority specific request.
• Maintain an update Product Information leaflets in region-specific packs in line with the most updated and approved US/ EU/ Swiss PIL due to SLC, 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.
• Communicate and coordinate with local RAs in Gulf / Levant the submission and approval of the updated PIL/ packs artworks.
• Launch and maintain region-specific packaging components (PIL and packs) via the One Art.
• Review and approve Printed Packaging Material Sheet (PPMS) received via One Art.
• Ensure timely submission and implementation of labeling changes through early and regular alignment with the cross-functional teams (NTO, global labeling, countries, supply chain, quality...)
• Collaborate with the quality team on any quality investigations related to labeling.
• Develop and maintain good relationship with the RA team in the Gulf/ Levant Clusters as well as Global RA/Labelling team.
• Create and maintain an updated NSS database for the whole active portfolio in Gulf/Levant in the Redi-Go (together with Labeling package).

Key performance indicators:

• Timely and accurate implementation of region-specific packs/PIL impacting product deliveries to the market
• Achievement of the compliance deliverables as per the Global targets when it is related to SLC/PIL/Pack update
• Maintain a 100% updated NSS database

Minimum Requirements:Education :

• Pharmacist or Bachelor is Sciences (Chemistry, biology or any other scientific degree)

Experience & Skills:

• At least 2-3 years practical experience in Middle East Labeling/ Regulatory Affairs
• General Knowledge of global regulatory affairs.
• Ability to critically evaluate data from a broad range of scientific disciplines
• Knowledge/experience of regulations, guidelines for product Labeling/ life cycle maintenance
• 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 cross-functional collaboration skills.
• Excellent English & Arabic required (oral and written)
• Excellent written / spoken interpersonal communication and negotiation skills
• Computer literacy

Skills Desired Detail-Oriented, Labeling Documentation, Labeling Regulations, Operational Excellence, Regulatory Compliance, Safety

Novartis