EU Regulatory Affairs Manager

Amgen Inc. (IR); Portugal; Presencial; EUR 49 000 - 66 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Flexible work arrangements

Total Rewards Plan

Resumo da oferta

AMGEN Capability Center Portugal, located in Lisbon, seeks an EU Regulatory Affairs Manager to ensure EU licenses for trials and products. Join a diverse, innovative team shaping healthcare through regulation and strategy in Europe.

The role involves planning regulatory submissions, guiding regional documents, and aligning with global strategies. Flexible work options and a strong rewards program accompany this opportunity.

Qualificações

• Degree educated with prior regulatory experience.
• Experience with registration procedures in the EU region (clinical trials, MA procedures, post-approval changes).
• Ability to develop regulatory strategies for products in development and post-marketing.

Responsabilidades

• Plan and manage regulatory submissions for EU products in compliance with EU requirements.
• Implement product regulatory strategies and planning in line with EU regulations.
• Provide content guidance for regional regulatory documents and meetings.
• Advise on regulatory mechanisms to optimize development (e.g., scientific advice, paediatric plans).
• Support EU label negotiation activities and regional strategy development.
• Develop predictions for regulatory outcomes and risks under supervision.
• Stay updated on new EU regulatory guidance and legislation.

Conhecimentos

Regulatory experience

EU regulatory submissions

Regulatory strategies

EU legislation knowledge

Communication skills

AI tools awareness

Formação académica

Degree educated

Descrição da oferta de emprego

Career Category Regulatory 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 we 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

• 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.

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.

What you can expect of us

As we work to develop treatments that take care of others, we also care deeply for our teammates’ well-being and growth. 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.

Salary Range

48,957.45 EUR - 66,236.55 EUR

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. For more information, visit www.amgen.com and follow us on www.twitter.com/amgen