EU Regulatory Affairs Manager - Flexible Work & Growth

Amgen; Lisboa; On-site; EUR 70,000 - 90,000; Full time

Benefits offered by this job

Flexible work arrangements

Total rewards plan

Job summary

Amgen Capability Center Portugal in Lisbon invites a seasoned EU Regulatory Affairs Manager to help secure and maintain EU licenses for investigational and marketed products. You will support one or more products from an EU regulatory perspective within Amgen's Europe team.

We seek candidates with hands-on registration experience, knowledge of EU legislation, and strong communication skills. The role involves regulatory strategy, submissions, and regional guidance to accelerate development while

Qualifications

• Degree educated in regulatory affairs or a related field.
• Experience registering medicines in EU regions (clinical trials, MAA procedures, post-approval changes).
• Strong written and verbal communication skills in English and local language.
• Ability to interpret EU regulatory legislation and policy for product development.

Responsibilities

• Plan and manage EU regulatory submissions (clinical trials, marketing applications) in line with global plans.
• Provide regional regulatory guidance and support market access strategies across EU.
• Contribute to development and execution of regional regulatory product strategies.
• Support EU label negotiations and regulatory forecasting.
• Stay updated on new EU regulations and evaluate impact on Amgen products.

Skills

Regulatory knowledge

Regulatory strategy

Communication skills

AI tools basic

Education

Degree in a relevant field

Job description

Amgen Capability Center Portugal in Lisbon invites a seasoned EU Regulatory Affairs Manager to help secure and maintain EU licenses for investigational and marketed products. You will support one or more products from an EU regulatory perspective within Amgen's Europe team.

We seek candidates with hands-on registration experience, knowledge of EU legislation, and strong communication skills. The role involves regulatory strategy, submissions, and regional guidance to accelerate development while