UK & Ireland Regulatory Strategy Leader

Amgen; Cambridge; Hybrid; GBP 90,000 - 120,000; Full time

Job summary

Amgen in the United Kingdom (Cambridge) is seeking a Senior Regulatory Affairs Manager to lead UK and Ireland regulatory activities. You will shape regulatory strategies, manage submissions, and oversee post-approval work across the region while coordinating with global teams to align with business objectives.

The role requires extensive UK regulatory experience, a strong track record in strategy, and leadership abilities to drive cross-functional programs in a fast-paced biotech environment.

Qualifications

• Degree educated in a scientific discipline
• Extensive experience in UK regulatory environment
• Proven track record of developing and executing UK regulatory strategy
• In-depth understanding of the drug life cycle and UK MA processes

Responsibilities

• Lead UK regulatory strategies, including risk assessment and contingency planning
• Plan and manage regulatory submissions (clinical trial and marketing applications)
• Provide strategic regulatory guidance to optimize product development
• Oversee post-approval activities in Ireland for Centrally Authorised products
• Lead preparation of regulatory documents and interactions with Health Authorities
• Collaborate with global and cross-functional stakeholders to align requirements

Skills

UK regulatory experience

Regulatory strategy

Leadership

Cross-functional collaboration

Education

Degree in science

Job description

Amgen in the United Kingdom (Cambridge) is seeking a Senior Regulatory Affairs Manager to lead UK and Ireland regulatory activities. You will shape regulatory strategies, manage submissions, and oversee post-approval work across the region while coordinating with global teams to align with business objectives.

The role requires extensive UK regulatory experience, a strong track record in strategy, and leadership abilities to drive cross-functional programs in a fast-paced biotech environment.