Gulf Regulatory Affairs Manager - Strategy & Compliance

Biopharma Careers; Dubai; On-site; AED 180,000 - 280,000; Full time

Benefits offered by this job

Total rewards

Job summary

Amgen is seeking a Regulatory Affairs Manager for the Gulf region to shape and execute regulatory strategies across multiple markets. You will manage submissions, ensure labeling compliance, and serve as the primary contact with Health Authorities.

The role requires 4–8+ years in Regulatory Affairs, knowledge of Gulf regulations, and strong cross‑functional collaboration to support product development and lifecycle management.

Qualifications

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

Responsibilities

• Contribute to local filing plans for Marketing Authorizations and lifecycle maintenance.
• Execute filing plans ensuring on-time, compliant submissions.
• Provide local regulatory input to product strategies.
• Review promotional and non-promotional materials for compliance.
• Review Patient Support Programs from a regulatory perspective.

Skills

Regulatory knowledge

Strategic thinking

Communication

Teamwork

Regulatory submissions

Education

Bachelor’s degree in pharmacy

Advanced degree preferred

Tools

Veeva Vault

RIM tools

CPP tool

Regulatory databases

Job description

Amgen is seeking a Regulatory Affairs Manager for the Gulf region to shape and execute regulatory strategies across multiple markets. You will manage submissions, ensure labeling compliance, and serve as the primary contact with Health Authorities.

The role requires 4–8+ years in Regulatory Affairs, knowledge of Gulf regulations, and strong cross‑functional collaboration to support product development and lifecycle management.