Regulatory Affairs Leader, Gulf Markets

Amgen SA; Dubai; On-site; AED 420,000 - 700,000; Full time

Job summary

Amgen is seeking a Regulatory Affairs Manager to shape and execute regulatory strategies across Gulf markets, including the UAE. You will align local and corporate requirements, manage timely submissions, and coordinate with health authorities to maintain compliance and lifecycle management.

You will lead cross‑functional teams, review materials for regulatory alignment, and contribute to strategic decisions on product development and labeling.

Qualifications

• Knowledge of regulatory principles, policies, and procedures.
• Experience with regulatory activities across Gulf markets.
• Proven ability to coordinate cross-functional teams.
• Ability to review and interpret regulations for drug products.
• Strong written and verbal communication skills.

Responsibilities

• Contribute to local filing plans for Marketing Authorizations and lifecycle maintenance.
• Execute the filing plan for the assigned Gulf countries.
• Provide regulatory input to product strategies and development plans.
• Review promotional and non-promotional materials for compliance.
• Oversee Patient Support Programs from a regulatory perspective.
• Assess digital health and software solutions from a regulatory angle.
• Gather and communicate competitive regulatory intelligence.
• Maintain regulatory data in systems (Veeva RIM, CPP tools).

Skills

Regulatory strategy

Regulatory submissions

Cross-functional collaboration

Regulatory intelligence

Communication skills

Project management

Education

Bachelor’s degree in pharmacy or related life sciences

Tools

Veeva Vault

RIM tools

Job description

Amgen is seeking a Regulatory Affairs Manager to shape and execute regulatory strategies across Gulf markets, including the UAE. You will align local and corporate requirements, manage timely submissions, and coordinate with health authorities to maintain compliance and lifecycle management.

You will lead cross‑functional teams, review materials for regulatory alignment, and contribute to strategic decisions on product development and labeling.