MEA Regulatory Affairs Senior Associate

About the role

Amgen is hiring a Regulatory Affairs Senior Associate for its Middle East and North Africa (MEA) region. The role covers labeling and packaging activities for the Amgen portfolio covering pipeline, inline and biosimilars, takes part in labeling projects internally and externally for e-labeling implementation, and executes Regulatory Affairs processes in the local office.

Key responsibilities

• Provide system support for lifecycle management and updates to existing platforms, ensuring data standards are accurate for reporting and analytics
• Manage performance excellence by collecting, analysing and sharing information with the team
• Take part in local regulatory process improvement initiatives
• Build newsletters and annual reports, analyse data and follow up on KPIs and metrics
• Ensure label source text is delivered correctly for artwork creation and support marketing application filings with regional product information (leaflet and SmPC) source texts and artworks
• Implement master artworks according to Amgen procedures, SKU strategy and timelines, and review translations and trigger label revisions
• Review prescribing information content and format, and act as source text owner and artwork reviewer
• Support product launches and supply continuity by creating and revising commercial pack artworks
• Share regulatory information with colleagues and advise on local regulatory considerations

Required profile

• At least 2 years of experience in Regulatory Affairs
• Current or previous experience within a multinational employer
• Pharmacist, biologist or chemist-medical background
• Fluent English and Arabic for translation review; French is a big plus
• Minimum knowledge of Middle East and Africa regulatory requirements

Required skills

• Strong verbal and written communication, able to explain scientific information and anticipate issues
• Ability to manage multiple stakeholders at once

What we offer

• Opportunities to learn and grow within a global organisation
• A diverse and inclusive community
• Total rewards plan covering health, finance and wealth, work-life balance and career benefits