Job Description

769 million lives touched by our products. Imagine what you could do at Novartis. No matter where you work, you could contribute to solving some of the toughest healthcare challenges and have an extraordinary impact on people's lives. Join us.

We are looking for a Labelling Lead responsible for Gulf & Levant to join our team. The role will be based in Dubai.

The role will be responsible for creating and updating the regional product information (RO2)/ PIL as well as the artworks related to the new product registrations and the maintenance of the registered products, for all countries within Gulf (including UAE), Levant. Additionally also responsible to create the BSS document for the whole portfolio to support the preparation of promotional materials for Gulf (including UAE), Levant as well as assume the review and validation of the P3 requests for the Gulf.

Labelling Project: PIL / packs Artwork update for Gulf (including UAE) / Levant
? Prepare the planning/strategy for regional PIL/ packs artwork update for Gulf / Levant in coordination with the relevant internal and external stakeholders.
? Prepare and coordinate the region- specific packs update for UAE / Gulf / Levant in line with the approved and updated Swiss Product Information following a maintenance update or to reply to Health Authority specific request.
? Maintain and update Product Information leaflets in region-specific packs in line with the most updated and approved 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 DRAs 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 Adaptable Quality Workflow Application (AQWA) and D2 DocStore ArtBase tools
? Review and approve Printed Packaging Material Sheet (PPMS) received via AQWA.
? 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/Labelling team.

NP4 Clearance:
? 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.
? Review and validate the promotional materials (P3) for the Gulf cluster.

Audit preparation:
Support Gulf, Levant and Saudi to be prepared for internal and external audits specifically for the SLC and P3 (PV audit/ GXP audit/ P3 audits).

Minimum requirements

? Degree in Pharmacy (e.g. Pharmacy, Biotechnology, Pharmacology, Quality Assurance) or equivalent
? Fluency in Arabic (oral and writing)
? Excellent English required (oral and written);

? At least 5 years practical experience in Middle East Regulatory Affairs
? Knowledge of global 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 skills
? Computer literacy
? Added experience from EU / US filings would be of advantage

Functional Area

Research & Development

Division

Global Drug Development

Business Unit

REG AFFAIRS GDD

Employment Type

Regular

Commitment to Diversity & Inclusion:

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Shift Work

No

Early Talent

No