Associate Regulatory Affairs Mea - Mansoura, مصر - Amgen

Amgen
Amgen
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Mansoura, مصر

منذ أسبوع

Fatima Mahmoud

تم النشر بواسطة:

Fatima Mahmoud

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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, chemistmedical 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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