Remote Regulatory Affairs Senior Manager – UK & Ireland

Amgen; Cambridge, Uxbridge; Hybrid; GBP 90,000 - 130,000; Full time

Job summary

Amgen seeks a Senior Regulatory Affairs Manager for the UK and Ireland. You will lead UK regulatory strategies, manage submissions, and guide lifecycle management across development and marketed products. Role requires leadership and strong collaboration within a global regulatory team.

You will work flexibly from home with regular office time at Cambridge or Uxbridge, supporting regulatory activities from development through marketing authorization.

Qualifications

• Degree educated in a scientific discipline
• Extensive experience in UK regulatory environment
• Proven track record of developing and executing UK regulatory strategy
• Understanding of the drug life cycle from a regulatory perspective
• Familiar with MA procedures, post-approval changes and renewals in the UK
• Ability to lead teams and collaborate across functions
• Proactive problem solving and strong communication with stakeholders
• Ability to anticipate regulatory agency expectations

Responsibilities

• Lead the development and execution of UK regulatory strategies, including risk assessment and contingency planning
• Plan and manage regulatory submissions (clinical trial and marketing) compliant with 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 interactions with Health Authorities
• Collaborate with global and cross-functional stakeholders to integrate UK and Ireland requirements

Skills

UK regulatory experience

Regulatory strategy development

Team leadership

Strategic thinking

Education

Degree in scientific discipline

Job description

Amgen seeks a Senior Regulatory Affairs Manager for the UK and Ireland. You will lead UK regulatory strategies, manage submissions, and guide lifecycle management across development and marketed products. Role requires leadership and strong collaboration within a global regulatory team.

You will work flexibly from home with regular office time at Cambridge or Uxbridge, supporting regulatory activities from development through marketing authorization.