Mea Regulatory Affairs Senior Associate

• 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
• Manage Performance Excellence through collection, analyzing & disseminating relevant information to team(s) as appropriate
• Participate in local regulatory process improvements initiatives
• Build newsletter, annual Report, data analysis with follow up on Key Performance Indicators and Metrics
• Ensure delivery of right first time label source text for artwork creation
• Support efficiently the filing plan of different marketing application submissions and products life cycle management filings by providing regional product information (leaflet and SmPC) source texts and artworks in a timely manner
• 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
• Support in product launch and ensure supply continuity by creating and revising the commercial pack artworks (leaflet, label, blister, outer pack)
• 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

• Experience +2 years in Regulatory Affairs
• Current/ previous experience in working as part of an MNC employer
• Pharmacist, biologist, chemist-medical background
• Fluent in English and Arabic for translation review purpose ( French is a huge plus)
• A minimum knowledge of Middle East Africa regulatory requirements
• Strong communication skills (verbal & written) with ability to understand and communicate the scientific information and anticipate/prevent potential issues
• Conflict Management skillset & ability to deal with multiple stakeholders simultaneously

French is a huge plus

• Vast opportunities to learn and move up and across our global organization
• Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
• Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits