Regulatory Affairs Manager
Amgen · Dubai, UAE
RegulatoryFull-timeCompany career page
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Role summary
Regulatory Affairs Manager position supporting Amgen's pharmaceutical portfolio across Gulf markets. The role involves developing and executing regulatory strategies, managing product submissions, ensuring compliance with local requirements, and serving as the primary contact with health authorities.
What they're looking for
- Knowledge of regulatory principles, policies, and standard operating procedures
- Understanding of national legislation and regulations for medicinal products
- Awareness of local registration procedures for clinical trials and marketing authorizations
- Experience in regulatory environment relevant to assigned product areas and development stages
- Understanding of drug development processes and ability to communicate implications
- Proficiency with regulatory systems such as Veeva RIM and related databases
What you'll be doing
- Develop and execute filing plans for marketing authorizations and lifecycle maintenance across assigned countries
- Ensure regulatory submissions are timely and compliant with corporate and local requirements
- Provide local regulatory input to product strategies and advise on mechanisms to optimize approvals
- Review promotional materials, patient support programs, and digital health solutions for regulatory compliance
- Serve as point of contact with health authorities and participate in regulatory agency interactions
Privacy & handoff
This role links to Amgen's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.