Regulatory Affairs Manager

About the role

Amgen is seeking a Regulatory Affairs Manager to shape and execute regulatory strategies for its portfolio across the Gulf markets. The role involves aligning local regulatory requirements with corporate standards, managing submissions, and serving as a point of contact with Health Authorities.

Key responsibilities

• Contribute to and execute local filing plans for Marketing Authorizations and lifecycle maintenance across Gulf countries.
• Provide regulatory input to product strategies, review promotional materials, and assess digital health solutions for compliance.
• Gather and communicate competitive regulatory intelligence and maintain regulatory data in systems such as Veeva RIM and CPP tools.
• Act as the primary liaison with regulatory agencies, preparing presentations on new regulations and monitoring external regulatory developments.

Required profile

• Bachelor’s degree in pharmacy or related life sciences (advanced degree advantageous).
• 4–8+ years of Regulatory Affairs experience with hands‑on new product registration and lifecycle management.
• Strong knowledge of Gulf (UAE, Kuwait, Qatar, Oman, Bahrain) legislation and regulations for medicinal products.
• Excellent teamwork, communication, negotiation, and cultural awareness skills.

Required skills

• Proficiency with regulated document and workflow systems (e.g., Veeva Vault, Veeva RIM).
• Experience using regulatory intelligence databases and CPP tools.

What we offer

• Competitive base salary aligned with local industry standards.
• Comprehensive Total Rewards Plans supporting professional and personal growth.