Regulatory Affairs Labeling coordinator
Novartis- Sandoz
Total years of experience :11 years, 1 Months
-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.
-To prepare the relevant comparison table for PIL update for Gulf & Levant, where relevant.
-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
-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 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/Labeling team.
-Support the preparation of promotional materials for Gulf & Levant.
-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
-Responsible for overseeing everyday operations of a pharmacy, training staff, maintaining stocks, liaising with suppliers, and solving patient inquiries.
-Ensure compliance with all applicable laws and regulations.
-Team management, Supervise team
-Liaise with physicians and patients to ensure proper dosage and lack of adverse drug interactions.
-Counsel patients on proper use of medication and potential side effects
-Increase sales and customer satisfaction
•Registering Pharmaceutical products (globally).
•Coordinate every necessary activity for preparation and evaluation of registrations dossiers and legal documents associated, and to direct and coordinate regulatory activities related to preparation of files for the new products registration processes, modifications, renewals and technical evaluations requirements for registration of products in the countries where they are needed.
•Preparing and sending required documents and giving support to local organizations for registration processes.
• Negotiating with authorities any problem related with registrations in process, to obtain the approval for initiate or continue the products commercialization.
•Ensuring that all Regulatory matters pertaining to healthcare facilities set-up and operations vis-à-vis licenses, approvals, statutory and regulatory compliances are met documented and tracked.
•Managing statutory and governmental inspections and ensuring all requirements pre and post the visit are met.
•Good experience in : MOH, DHA , HAAD, DHCC, Dubai Municipality, DED Department of Economic Development (Dubai, Sharjah , Abu Dhabi ) .
•Regulatory affairs of medical practices to be ensured through proper channels.
•Responsible for all administration aspects of managing medical operating licenses, periodic renewals, documentation.
•Managing all aspects of company’s operating licenses - liaising with internal departments and resources for internal documentation and with the various Ministries and Departments (external) to ensure all statutory paperwork is in order. This involves all statutory paperwork from creation to renewals.
•All regulations specific to the medical business need to be met including documentation audits.
•Liaison to Company Secretary/In-house legal attorney for legal aspects of company administration with specific relation to licenses, visas and other compliances.
•Managing confidential records of the company AOA- MoA, Licenses, Facility Audit reports, etc.
•Responsible for working with Affiliates and providing support for the implementation of new or revised secondary packaging components and/or labeling artwork.
•Evaluate content of labeling updates and raise issues with Labeling Strategy as appropriate.
•Identify appropriate Market Approvers for packaging artwork and electronically route for approval using ePalms lifecycle management.
•Interact and follow up with all Market Approvers, as needed, and address regulatory content issues as they arise during the approval process.
•Lead teams in development and revisions of relevant SOP’s for functional area.
•Work with related functions (Engineering, Supply, Manufacturing, Quality, Country Regulatory team and Pfizer global functions) to ensure all documentation completed according to the required timelines
Technical
•Preparation of new labels and artworks for Pfizer products within agreed timeline.
•Updating current labels to match reference markets documents within agreed timeline.
•Identifying labeling issues as: errors, inconsistencies, conflicts, etc., between package leaflet text statements and reference documents and acting decisively to solve such issues.
•Responsible for artwork updates via 3rd party vendor
•Follow up with the 3rd party vendor to develop agreed artwork within specific timeline
•Upload the final AWs on the epalms system as AWs.
•Initiating, processing, tracking, follow up & ensuring implementation of labels on Pharmaceutical electronic label system and / or Nutrition label system
•Accountable for processing and reviewing of MENA language translation (Arabic, Farsi…etc) of labels and rectifying errors immediately in-house or via third party
•Archiving all project documents which include final artworks, approvals, and forms, reference documents in both soft & hard copies.
•Chemical and physical analysis of Pharmaceutical raw material and finish products in Quality control laboratory in Pharmaceutical industry.
•Good experience: HPLC-UV-IR- Karl Fischer ….etc
Pharmacist with DHA License
