Senior Regulatory Affairs Lead – UK & Ireland

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

Job summary

Amgen UK is seeking a Regulatory Affairs Senior Manager to lead UK regulatory strategy across the UK and Ireland, shaping plans for clinical development and commercialization. You’ll ensure alignment with regulatory requirements and business goals while guiding teams through submissions and post-approval activities.

You will partner with global stakeholders to integrate regulatory requirements into product strategies and help navigate complex regulatory pathways from development to lifecycle

Qualifications

• Degree in a scientific discipline.
• Extensive experience within UK regulatory environment.
• Proven track record of developing and executing UK regulatory strategy.
• Deep understanding of drug life cycle and regulatory processes in the UK.

Responsibilities

• Lead UK regulatory strategies, including risk assessment and contingency planning.
• Plan and manage regulatory submissions (clinical trials, marketing); align with global plans.
• Provide strategic guidance to optimize product development and lifecycle management.
• Oversee post-approval activities in Ireland for Centrally Authorised products.
• Prepare regulatory documentation and interactions with Health Authorities.
• Collaborate with global and cross-functional teams to integrate UK/IE regulatory requirements.

Skills

Regulatory strategy

UK regulatory environment

Regulatory submissions

Lifecycle management

Stakeholder collaboration

Regulatory documentation

Regulatory risk assessment

Problem solving

Education

Degree in scientific discipline

Job description

Amgen UK is seeking a Regulatory Affairs Senior Manager to lead UK regulatory strategy across the UK and Ireland, shaping plans for clinical development and commercialization. You’ll ensure alignment with regulatory requirements and business goals while guiding teams through submissions and post-approval activities.

You will partner with global stakeholders to integrate regulatory requirements into product strategies and help navigate complex regulatory pathways from development to lifecycle