Mea Regulatory Affairs Senior Associate

Amgen

Egypt
On-site
Labeling and packaging activities management
E-labeling implementation
Local regulatory process improvements
Amgen is seeking a MEA Regulatory Affairs Senior Associate in Egypt to manage labeling and packaging activities for its portfolio in the Middle East and North Africa region. The ideal candidate should have at least two years of experience in Regulatory Affairs, a background in pharmacy, biology, or chemistry, and be fluent in English and Arabic

Job Summary

  • As a member of this fast-pace, complex and dynamic region, MEA Regulatory Affairs Senior Associate will be accountable for labeling and packaging activities management for Middle East North African region for Amgen portfolio for pipeline, inline and biosimilars.
  • 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.
  • Vast opportunities to learn and move up and across our global organization.

Matching Summary

Match Score: 85

Amgen is seeking a MEA Regulatory Affairs Senior Associate in Egypt to manage labeling and packaging activities for its portfolio in the Middle East and North Africa region. The ideal candidate should have at least two years of experience in Regulatory Affairs, a background in pharmacy, biology, or chemistry, and be fluent in English and Arabic.

Skills & Requirements

Must-have

  • labeling and packaging activities management
  • e-labeling implementation
  • local regulatory process improvements
  • master artworks implementation
  • translation agency systems access
  • regional prescribing information translation review
  • source text owner/approver
  • artwork reviewer/approver
  • product launch support
  • regulatory information exchange

Nice-to-have

  • strategic and administrative system support
  • performance excellence management
  • key performance indicators tracking
  • anticipate/prevent potential issues
  • deal with multiple stakeholders

Key Requirements

  • +2 years in Regulatory Affairs
  • Experience in MNC employer
  • Pharmacist, biologist, chemist-medical background
  • Fluent in English and Arabic
  • Minimum knowledge of MEA regulatory requirements

Work Rights

Not specified

Tailored Resume

Cover Letter