Regulatory Affairs Manager: Gulf Markets Strategy

amgen; Dubai; On-site; AED 450,000 - 600,000; Full time

Job summary

Amgen Dubai is seeking a Regulatory Affairs Manager to shape regulatory strategies for Gulf markets, ensuring compliant submissions and alignment with corporate standards. You will collaborate with cross-functional teams to manage product labeling, lifecycle activities, and interactions with Health Authorities.

You will oversee local filings, provide regulatory input to development plans, and mentor junior staff while contributing to continuous process improvements and regulatory intelligence

Qualifications

• Bachelor's degree in pharmacy or related life sciences; 4-8+ years of Regulatory Affairs experience.
• In-depth knowledge of Gulf regulations and local Health Authority processes.
• Experience with product registrations, lifecycle management, and regulatory submissions.

Responsibilities

• Develop and execute regulatory strategies for Gulf markets and ensure timely submissions.
• Review labeling, promotions, and Patient Support Programs for regulatory compliance.
• Interact with Health Authorities and coordinate cross-functional teams.

Skills

Regulatory knowledge

Communication

Teamwork

Problem solving

Education

Bachelor's degree in pharmacy

Advanced degree preferred

Tools

Veeva Vault

RIM tools

Job description

Amgen Dubai is seeking a Regulatory Affairs Manager to shape regulatory strategies for Gulf markets, ensuring compliant submissions and alignment with corporate standards. You will collaborate with cross-functional teams to manage product labeling, lifecycle activities, and interactions with Health Authorities.

You will oversee local filings, provide regulatory input to development plans, and mentor junior staff while contributing to continuous process improvements and regulatory intelligence