EU Regulatory Affairs Manager

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

Join our team at AMGEN Capability Center Portugal, consistently recognized among the top companies in the Best Workplaces ranking by Great Place to Work in Portugal. In 2026, we were once again distinguished as one of the top Best Workplaces in the country (category 201–500 employees), reinforcing our commitment to an exceptional employee experience and workplace culture.

We are a team of over 500 talented individuals, spanning more than 30 functions and areas of expertise, and representing over 40 nationalities. Together, we bring diverse perspectives and professional backgrounds to help shape the future of healthcare through innovation and technology.

This is your opportunity to explore a world of possibilities across areas such as Data & Analytics, Digital, Technology & Innovation, Cybersecurity, R&D Operations, Global Distribution, Finance, Regulatory Affairs, General & Administrative, Human Resources, and many more.

Located in the heart of Lisbon, our AMGEN office fosters a culture of innovation, excellence, and purpose. Come thrive with us at AMGEN, supporting our mission To Serve Patients.

What we do at AMGEN matters in people’s lives.

EU REGULATORY AFFAIRS MANAGER

LIVE

What You Will Do

In this vital role you will work to ensure that Amgen acquires and maintains all the required EU licenses in order to support clinical trials for investigational medicinal products as well as marketed medicinal products. You will support one or more products from an EU regulatory perspective.

We are currently looking for x3 EU Regulatory Affairs Managers between Portugal and the United Kingdom, joining the EU Oncology or General Medicine teams, part of the Global Regulatory Affairs function in Europe.

Strategy and Execution

• Depending on business needs and experience, the role may include EU Regulatory Lead responsibility for one or more products.
• Plan and manage regulatory submissions (e.g. clinical trial and marketing applications) for products within Amgen's portfolio in compliance with global filing plans and EU regional regulatory requirements.
• Under general supervision, implement product related regulatory strategies, Regulatory Affairs processes and activity planning in accordance with EU regional legislation and regulatory requirements. Provide content guidance for regional regulatory documents and meetings in accordance with global strategy.
• Provide regulatory guidance on regional regulatory mechanisms to optimize product development (e.g. expediting FIH studies, scientific advice, Orphan Drug, MA approval mechanisms and paediatric plans).
• Support EU label negotiation activities.
• Under general supervision participate in the development and execution of regional regulatory product strategies.
• Under general supervision, develop predictions for expectations and risks associated with outcomes by regulatory agencies.

Regulatory Research

• Maintain an awareness of new and developing legislation, regulatory policy and technical Regulatory guidance relating to Amgen products.
• Perform regulatory research to obtain relevant histories, precedence and other information relevant to regional product advancement.
• Under supervision evaluate and communicate impact of relevant regional regulations, guidances, current regulatory environment and competitor labelling.

WIN

What We Expect Of You

We are all different, yet we all use our unique contributions to serve patients. What we seek in you as an experienced professional, are these qualifications and skills:

• Degree educated and previous experience in a similar role
• Hands-on experience with registration procedures in the region, such as clinical trials, pre-MAA regulatory procedures (eg scientific advice, orphan applications or Paediatric Investigation Plans (PIPs)), MA, post-approval changes, extensions and renewals
• Experience developing regulatory strategies for products in clinical development and post-marketing phases.
• Knowledge of EU legislation and regulations relating to medicinal products
• Working with policies, procedures and SOP’s .
• Strong communication skills - both oral and written.
• Ability to anticipate and prevent potential issues.Ability to resolve conflicts and develop a course of action leading to a beneficial outcome.
• Basic proficiency in using AI tools to support day-to-day work.

THRIVE

What You Can Expect Of Us

• Vast opportunities to learn, develop, and move up and across our global organization.
• Diverse and inclusive community of belonging, where colleagues are empowered to bring ideas to the table, take risks, and act.
• Generous AMGEN Total Rewards Plan comprising healthcare, finance, wealth, and career benefits.
• Flexible work arrangements.

EQUAL OPPORTUNITY STATEMENT

AMGEN is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.