Not specified; not specified; generous total rewar...
Not specified
Bachelor's degree in pharmacy or life sciences
4-8+ years regulatory affairs experience
Labeling and artwork lifecycle management
Amgen Australia Pty Ltd is seeking a Regulatory Affairs Manager for the Middle East and Africa (MEA) markets. The role involves managing local product labeling and packaging compliance, requiring significant experience in regulatory affairs and knowledge of regional requirements
Job Summary
The role is accountable for the end-to-end execution of compliant, accurate, and timely local product labeling and packaging deliverables across assigned MEA markets.
Amgen is a global biotechnology company driven by a shared mission to serve patients and deliver ever-better products to over 10 million patients worldwide.
Candidates will manage translation workflows, perform 100% translation review, and ensure supply-readiness timelines are met for packaging and artwork lifecycle activities.
Matching Summary
Match Score: 85
Amgen Australia Pty Ltd is seeking a Regulatory Affairs Manager for the Middle East and Africa (MEA) markets. The role involves managing local product labeling and packaging compliance, requiring significant experience in regulatory affairs and knowledge of regional requirements.
Salary
Not specified; Not specified; Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits
Skills & Requirements
Must-have
Bachelor's degree in Pharmacy or life sciences
4-8+ years Regulatory Affairs experience
Labeling and artwork lifecycle management
Experience within MNCs
Knowledge of Middle East & Africa regulatory requirements
Proficiency in Veeva Vault or RIM tools
Nice-to-have
French literacy preferred
Arabic language skills preferred
Advanced degree advantage
Biosimilars labeling experience
Track-and-trace serialization knowledge
Key Requirements
Bachelor's degree in Pharmacy or related life sciences
4–8+ years of Regulatory Affairs experience
Current or previous experience within MNCs
English language proficiency required
Proficiency with regulated document systems like Veeva Vault