Associate Regulatory Affairs - Based In Egypt

Amgen

Egypt
On-site
Manage country-specific regulatory affairs
Coordinate regulatory submissions
Ensure compliance with requirements
Amgen is seeking an Associate Regulatory Affairs professional based in Egypt to manage regulatory submissions and ensure compliance with local and corporate requirements. The ideal candidate should possess a Bachelor's degree in Pharmaceutical Science and have a comprehensive understanding of regulatory principles and drug development

Job Summary

  • Manage country-specific regulatory affairs for Amgen's molecules, coordinating and implementing regulatory submissions.
  • Ensure compliance with corporate and local requirements and lead documentation for local submissions under Senior Manager's guidance.
  • Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

Matching Summary

Match Score: 80

Amgen is seeking an Associate Regulatory Affairs professional based in Egypt to manage regulatory submissions and ensure compliance with local and corporate requirements. The ideal candidate should possess a Bachelor's degree in Pharmaceutical Science and have a comprehensive understanding of regulatory principles and drug development.

Skills & Requirements

Must-have

  • Manage country-specific regulatory affairs
  • Coordinate regulatory submissions
  • Ensure compliance with requirements
  • Prepare and archive submission documentation
  • Review promotional materials

Nice-to-have

  • Partner with international Regulatory Leads
  • Exchange regulatory intelligence
  • Participate in process improvements

Key Requirements

  • Bachelor's degree in Pharmaceutical Science
  • Knowledge of Regulatory Principles
  • Experience with policies, procedures and SOPs
  • Understanding of drug development
  • Ability to work in teams
  • Ability to communicate scientific/clinical information

Work Rights

Not specified

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