Global Regulatory Affairs Manager (homebased)

IQVIA UK

Dubai, United Arab Emirates
Fully remote
Regulatory submission preparation
Health authority communication
Product labelling preparation
You will be responsible for regulatory activities required at a country level for pharmaceutical products, including maintenance and approvals, marketing authorization transfers, communication with the Health Authority, artwork approval etc. ensuring regulatory compliance in the applicable market(s)

Job Summary

  • You will be responsible for regulatory activities required at a country level for pharmaceutical products, including maintenance and approvals, marketing authorization transfers, communication with the Health Authority, artwork approval etc. ensuring regulatory compliance in the applicable market(s).
  • Manage the local regulatory submission preparation in collaboration with internal and external stakeholders based on the agreed strategy for designated countries.
  • Give guidance to junior colleagues, including feedback on the quality of technical documents, and may assist in their training and development.

Matching Summary

You will be responsible for regulatory activities required at a country level for pharmaceutical products, including maintenance and approvals, marketing authorization transfers, communication with the Health Authority, artwork approval etc. ensuring regulatory compliance in the applicable market(s).

Skills & Requirements

Must-have

  • regulatory submission preparation
  • Health Authority communication
  • Product Labelling preparation
  • artwork review and approval
  • Chemistry, Manufacturing & Controls expertise
  • Lifecycle Maintenance expertise
  • Marketing Authorization Transfers expertise

Nice-to-have

  • customer relationship management
  • internal regulatory training delivery
  • bid defense meeting presentation
  • self-motivation and enthusiasm
  • adaptability to changing environments

Key Requirements

  • 8-10+ years of prior relevant experience
  • Master's Degree in Life science or related discipline
  • Fluent in English language
  • Fluent in Arabic

Work Rights

Not specified

Tailored Resume

Cover Letter