Career Category
Regulatory
Job Description
Job Summary:
* Coordination and execution of Regulatory Affairs processes and deliverables in the local office: publishing, SharePoint maintenance, statistics analysis , reporting.
* Labeling and packaging activities management for Middle East North African region for Amgen portfolio
Key Activities:
* Systems Management to deliver both strategic and administrative system support for ongoing maintenance with Lifecyle management and updates to our existing platforms and systems, to ensure data standards are 100% accurate, as to enable effective reporting and data analytics
* Performance Excellence Management through collection, analyzing & disseminating relevant information to team(s) as appropriate
* Participate in local regulatory process improvements initiatives
* Build & share newsletter, annual Report, data analysis with follow up on Key Performance Indicators and Metrics
* Intelligence Gathering
* Perform Publishing and System driven activities
* Ensure delivery of right first time label source text for artwork creation
* Support efficiently products life cycle management by providing regional product information (leaflet and SmPC) source texts and artworks in a timely manner
* Perform label management within the system from CDS (product core data sheet) update to variation submission in the region
* Ensure implementation of master artworks as per Amgen procedures, SKU strategy and timelines with high quality to serve our patients in MENA region
* Access the translation agency systems to request the label translation and track the job readiness and timelines.
* Perform regional prescribing information translation review: 100% review of both content and format
* Perform the role of source text owner/approver and artwork reviewer/approver in the system
* Trigger the existing label revision when alerted by global RA team.
* Disseminate relevant information to team(s) as appropriate
* Collate, distribute and exchange regulatory information with other regulatory colleagues and cross functional teams on an ongoing basis and provide advice on local regulatory considerations in a timely manner.
* Provide centralized support for SPO maintenance, statistical analysis, reporting monthly and annually.
Requirements
* Pharmacist, biologist, chemist-medical background with Project Management Skills
* Fluent in English and Arabic for translation review purpose, French is an advantage
* Hard worker, fast learner, positive attitude, team spirit, willing to take on challenges, details oriented.
* Strong communication skills both oral and written, with ability to understand and communicate the scientific information and anticipate/prevent potential issues
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**Job Summary:** * Coordination and execution of Regulatory Affairs processes and deliverables in the local office: publishing, SharePoint maintenance, statistics analysis , reporting. * Labeling and packaging activities management for Middle East North African region for Amgen portfolio **Key…
**Job Summary:** **** * Labeling and packaging activities management for Middle East North African region for Amgen portfolio * Coordination and execution of Regulatory Affairs processes and deliverables in the local office: publishing, SharePoint maintenance, statistics analysis , reporting. …
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