Remote UK & Ireland Regulatory Affairs Senior Manager

Amgen; Uxbridge Moor; Hybrid; GBP 95,000 - 135,000; Full time

Job summary

Amgen seeks a Regulatory Affairs Senior Manager for the UK & Ireland, with responsibility for regulatory strategy across the UK and Ireland, including post-approval activities in Ireland for Centrally Authorised products. You will lead regulatory submissions, provide strategic guidance, and collaborate with global teams to align local requirements with business objectives.

You will work flexibly from home with regular office work in Cambridge or Uxbridge, contributing to Amgen's mission to

Qualifications

• Degree educated in a scientific discipline.
• Extensive experience in UK regulatory environment.
• Proven track record of developing and executing UK regulatory strategy.

Responsibilities

• Lead regulatory activities across the UK and Ireland, shaping strategies and submissions.
• Plan and manage regulatory submissions (clinical trials, marketing applications) in line with local and global plans.
• Provide strategic regulatory guidance to optimize product development and lifecycle management.
• Oversee post-approval activities in Ireland for Centrally Authorised products, ensuring local compliance.
• Coordinate with Health Authorities and stakeholders to integrate UK/IE requirements into product strategies.

Skills

UK regulatory experience

Regulatory strategy

Team leadership

Regulatory submissions

Problem solving

Education

Science degree

Job description

Amgen seeks a Regulatory Affairs Senior Manager for the UK & Ireland, with responsibility for regulatory strategy across the UK and Ireland, including post-approval activities in Ireland for Centrally Authorised products. You will lead regulatory submissions, provide strategic guidance, and collaborate with global teams to align local requirements with business objectives.

You will work flexibly from home with regular office work in Cambridge or Uxbridge, contributing to Amgen's mission to