Strategic Regulatory Affairs Manager, Gulf Markets

Amgen

Dubai

On-site

AED 446,000 - 781,000

Full time

18 hours ago
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Job summary

Amgen is seeking a Regulatory Affairs Manager to lead regulatory strategies for Gulf markets (UAE, Kuwait, Qatar, Oman, Bahrain). You will collaborate with cross-functional teams to ensure compliant submissions, labeling, and lifecycle management across assigned products.

The role requires strong regulatory knowledge, hands-on experience with local authorities, and the ability to coordinate with global leads. You will mentor junior staff and contribute to strategy and policy updates.

Qualifications

  • Bachelor’s degree in pharmacy or related life sciences is required.
  • Typically 4–8+ years of Regulatory Affairs experience with strong hands-on registration experience.
  • In-depth knowledge of Gulf (UAE, Kuwait, Qatar, Oman and Bahrain) regulations is preferred.

Responsibilities

  • Contribute to the local filing plan for Marketing Authorizations and lifecycle maintenance with cross-functional teams.
  • Execute filing plans for assigned countries ensuring timely submissions meeting requirements.
  • Review promotional materials for regulatory compliance and provide guidance on local rules.
  • Interact with Health Authorities and support regulatory strategy development.

Skills

Regulatory knowledge
Regulatory strategy
Cross-functional collaboration
Communication
Regulatory research
Problem solving

Education

Bachelor's degree in Pharmacy or related life sciences
Advanced degree advantageous

Tools

Veeva Vault
RIM tools
CPP tool

Job description

Amgen is seeking a Regulatory Affairs Manager to lead regulatory strategies for Gulf markets (UAE, Kuwait, Qatar, Oman, Bahrain). You will collaborate with cross-functional teams to ensure compliant submissions, labeling, and lifecycle management across assigned products.

The role requires strong regulatory knowledge, hands-on experience with local authorities, and the ability to coordinate with global leads. You will mentor junior staff and contribute to strategy and policy updates.

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