Regulatory Affairs Lead, Gulf Markets

Amgen Inc. (IR); Dubai; On-site; AED 180,000 - 260,000; Full time

Benefits offered by this job

Total Rewards Plans

Job summary

Amgen Inc. (IR) is seeking a Regulatory Affairs Manager to lead regulatory strategies across the Gulf markets, aligning local regulatory requirements with corporate standards.

You will manage submissions, labeling, and compliance while serving as a primary contact with Health Authorities. The role emphasizes local strategy input, filing plan execution, and cross‑functional collaboration to support product development and lifecycle management.

Qualifications

• Bachelor’s degree in pharmacy or related life sciences (required); advanced degree is an advantage.
• Typically, 4–8+ years of Regulatory Affairs experience with strong hands‑on new product registration and lifecycle management.
• In-depth knowledge of the Gulf (UAE, Kuwait, Qatar, Oman and Bahrain) legislation and regulations relating to medicinal products is preferred.

Responsibilities

• Contribute to the local filing plan for Marketing Authorizations and lifecycle maintenance, advising and aligning with the local cross‑functional team.
• Execute the filing plan for the assigned country(ies), ensuring submissions are made on time and meet corporate and local regulatory requirements.
• Provide local regulatory input to product strategies and advise on local mechanisms that may optimize product development and regulatory approvals.
• Review and approve promotional and non‑promotional materials in accordance with applicable procedures and local requirements.
• Own and maintain the quality, completeness, accuracy, and timeliness of regulatory data in designated systems and tools.

Skills

Regulatory strategy

Cross-functional teamwork

Regulatory intelligence

Documentation & submissions

Education

Bachelor’s degree in pharmacy or life sciences

Tools

Veeva Vault

RIM tools

CPP tool

Regulatory databases

Job description

Amgen Inc. (IR) is seeking a Regulatory Affairs Manager to lead regulatory strategies across the Gulf markets, aligning local regulatory requirements with corporate standards.

You will manage submissions, labeling, and compliance while serving as a primary contact with Health Authorities. The role emphasizes local strategy input, filing plan execution, and cross‑functional collaboration to support product development and lifecycle management.