EU Regulatory Affairs Manager — Hybrid/Remote

Amgen; United Kingdom; Hybrid; GBP 90,000 - 120,000; Full time

Benefits offered by this job

Growth opportunities

Inclusive culture

Total rewards plan

Job summary

Amgen in the United Kingdom is seeking an EU Regulatory Affairs Manager to lead regulatory activities across multiple UK locations and remote. The role covers planning submissions, regulatory strategy, and guidance for EU/UK regions within Oncology or General Medicine teams.

You will work with cross-functional partners to maintain licenses, support trials, and navigate EU regional requirements. Flex commuter / hybrid work arrangements apply with occasional office days in Cambridge or Uxbridge.

Qualifications

• Degree education and experience in regulatory roles
• Experience planning and managing submissions (clinical trials, MAAs)
• Strong understanding of EU regulations and regional requirements
• Ability to lead/regulatory strategy discussions and provide guidance

Responsibilities

• Plan and manage regulatory submissions for EU/UK products
• Provide regulatory guidance on regional strategies and mechanisms
• Support EU label negotiations and product lifecycle activities
• Develop regional regulatory product strategies under supervision

Skills

Regulatory experience

Communication

Problem solving

AI tools

Education

Degree educated

Job description

Amgen in the United Kingdom is seeking an EU Regulatory Affairs Manager to lead regulatory activities across multiple UK locations and remote. The role covers planning submissions, regulatory strategy, and guidance for EU/UK regions within Oncology or General Medicine teams.

You will work with cross-functional partners to maintain licenses, support trials, and navigate EU regional requirements. Flex commuter / hybrid work arrangements apply with occasional office days in Cambridge or Uxbridge.