Regulatory Affairs Senior Manager - UK and Ireland

Amgen seeks a Regulatory Affairs Senior Manager to lead regulatory strategy and submissions across the UK and Ireland. The role encompasses clinical trial approvals, marketing authorization applications, post-approval compliance, and cross-functional collaboration to support product development and commercialization.

Responsibilities

• Lead development and execution of UK regulatory strategies, including risk assessment and pathway planning
• Plan and manage regulatory submissions for clinical trials and marketing applications per local and global requirements
• Provide strategic regulatory guidance to optimize product development and lifecycle management
• Oversee post-approval regulatory activities in Ireland for centrally authorised products
• Lead preparation of regulatory documentation and manage interactions with Health Authorities

Requirements

• Degree in a scientific discipline
• Extensive experience in UK regulatory environment
• Proven track record developing and executing UK regulatory strategy
• In-depth knowledge of drug lifecycle and development from regulatory perspective
• Strong understanding of UK registration procedures for MA, post-approval changes, extensions, and renewals
• Team leadership and collaborative skills in dynamic environments
• Ability to anticipate regulatory agency expectations and communicate scientific information