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Amgen Logo Amgen · IT - Administration

Regulatory Affairs Manager

Egypt, Cairo · Job Posted May 05, 2026
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Job Description

If you feel like you're part of something bigger, it's because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world's leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It's time for a career you can be proud of. Join us.

Job Responsibility

  • High-quality and timely Regulatory Affairs input to planned filings and approvals of new marketing authorizations (MA) and line-extensions
  • Maintain established products according to global and local regulatory plans
  • Update and maintain regulatory databases
  • Handle Health Authorities requests
  • Build and keep a highly professional relationship with the Medicines Agency
  • Support and interact with global regulatory affairs, QA, Market Access, Marketing (projects and product teams) and Sales to best support local and global strategy
  • Monitor future trends in regulatory affairs which are likely to affect AMGEN interest
  • Perform or facilitate audits to ensure compliance

Requirements

  • A bachelor's degree in Pharmacy or any relevant field
  • Minimum of 6 years of regulatory experience in the pharmaceutical industry or with Health Authorities
  • Excellent current regulatory knowledge understanding of US FDA and EMEA regulatory guidelines
  • Advanced ability to interpret scientific data and to construct persuasive regulatory documents
  • Good communication skills, ability to work effectively in a matrix setup
  • Strong knowledge of regulatory life cycle maintenance
  • Having People Management experience is critical
  • An analytical approach balanced with a keen eye for detail demonstrated in all document control and administration undertaken
  • Strong communication and leadership skills with the ability to select, motivate, train, and develop staff to achieve company goals

What we offer

  • 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
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