UK & Ireland Regulatory Lead: Strategy & Submissions

Amgen; Manor Park; Hybrid; GBP 90,000 - 120,000; Full time

Job summary

Amgen in the United Kingdom seeks a senior Regulatory Affairs leader to drive UK regulatory strategy across the lifecycle of medicines, including submissions and post-approval activities in Ireland. You will influence global plans and ensure alignment with business objectives.

The role requires extensive UK regulatory experience, a scientific degree, and a proven ability to lead cross-functional teams in a dynamic environment.

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 the development and execution of UK regulatory strategies, including risk assessment and contingency planning.
• Plan and manage regulatory submissions, including clinical trial and marketing applications, in line with local requirements and global strategies.
• 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 regulatory requirements.

Skills

UK regulatory experience

Regulatory strategy development

Team leadership

Regulatory submissions

Communication of scientific info

Education

Bachelor's degree in a scientific discipline

Job description

Amgen in the United Kingdom seeks a senior Regulatory Affairs leader to drive UK regulatory strategy across the lifecycle of medicines, including submissions and post-approval activities in Ireland. You will influence global plans and ensure alignment with business objectives.

The role requires extensive UK regulatory experience, a scientific degree, and a proven ability to lead cross-functional teams in a dynamic environment.