Mea Regulatory Affairs Senior Associate

Amgen Australia Pty Ltd

Labeling and packaging activities management
E-labeling implementation
Regulatory affairs processes execution
As a member of this fast-pace, complex and dynamic region, MEA Regulatory Affairs Senior Associate will be accountable for l abeling and packaging activities management for Middle East North African region for Amgen portfolio for pipeline, inline and biosimilars; as well p articipating in labeling projects internally and externally for e-labeling implementation; and execution of Regulatory Affairs processes in the local office

Job Summary

  • As a member of this fast-pace, complex and dynamic region, MEA Regulatory Affairs Senior Associate will be accountable for l abeling and packaging activities management for Middle East North African region for Amgen portfolio for pipeline, inline and biosimilars; as well p articipating in labeling projects internally and externally for e-labeling implementation; and execution of Regulatory Affairs processes in the local office.
  • 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 Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act

Matching Summary

As a member of this fast-pace, complex and dynamic region, MEA Regulatory Affairs Senior Associate will be accountable for l abeling and packaging activities management for Middle East North African region for Amgen portfolio for pipeline, inline and biosimilars; as well p articipating in labeling projects internally and externally for e-labeling implementation; and execution of Regulatory Affairs processes in the local office.

Skills & Requirements

Must-have

  • labeling and packaging activities management
  • e-labeling implementation
  • Regulatory Affairs processes execution
  • master artworks implementation
  • product launch support

Nice-to-have

  • global collaborators
  • diverse and inclusive community
  • professional and personal growth

Key Requirements

  • +2 years in Regulatory Affairs
  • Pharmacist, biologist, chemist-medical background
  • Fluent in English and Arabic
  • Minimum knowledge of Middle East Africa regulatory requirements
  • Strong communication skills

Work Rights

Not specified

Tailored Resume

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