EU Regulatory Affairs Manager

Amgen SA; Lisboa; Híbrido; EUR 70 000 - 100 000; Tempo integral

Resumo da oferta

AMGEN Capability Center Portugal in Lisbon seeks an experienced EU Regulatory Affairs Manager to ensure regulatory submissions and strategies across the EU region. You will support one or more products from an EU regulatory perspective within Amgen’s Europe operations.

The role involves collaboration with Global Regulatory Affairs teams, exposure to clinical trials, MA procedures, and regional regulatory processes. Excellent knowledge of EU legislation and strong communication are essential.

Qualificações

• Degree educated and previous experience in a similar role.
• Hands-on experience with registration procedures in the region (clinical trials, MA procedures, PAIPs, etc.).
• Experience developing regulatory strategies for products in clinical development and post-marketing phases.
• Knowledge of EU legislation and regulations relating to medicinal products.
• Strong communications skills - oral and written.
• Ability to anticipate and prevent potential issues.
• Ability to resolve conflicts and develop a course of action.
• Basic proficiency in using AI tools to support day-to-day work.

Responsabilidades

• Plan and manage regulatory submissions for products within Amgen's portfolio.
• Provide regulatory guidance on regional documents and meetings.
• Support EU label negotiation activities.
• Develop regional regulatory product strategies under supervision.
• Maintain awareness of new EU regulations and guidance.

Conhecimentos

Degree educated

EU registration procedures

Regulatory strategies

EU legislation knowledge

Strong communication

Anticipation of issues

Conflict resolution

AI tools for work

Formação académica

Bachelor's degree in Life Sciences or related field

Descrição da oferta de emprego

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.

EUREGULATORY AFFAIRS MANAGER

LIVE

What you will do

In this vital role you will work to ensure that Amgenacquiresandmaintainsall the requiredEUlicensesin order tosupport clinical trials for investigational medicinal products as well as marketedmedicinal products.You will support one or more products fromanEUregulatory perspective.

We are currently looking for x3EURegulatory Affairs Managers between Portugal and the United Kingdom, joining theEUOncology 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 includeEU Regulatory Leadresponsibilityfor 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 andEUregionalregulatory requirements.

• Under general supervision, implement product related regulatory strategies, Regulatory Affairsprocessesand activity planningin accordance withEU regionallegislation and regulatoryrequirements. Providecontent guidance for regional regulatory documents and meetingsin accordance withglobal strategy.

• Provideregulatory guidance on regional regulatory mechanisms tooptimizeproduct development (e.g.expediting FIH studies,scientificadvice,Orphan Drug,MA approvalmechanismsandpaediatricplans).

• SupportEUlabel negotiation activities.

• Under general supervisionparticipatein 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,precedenceand 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 weseekin you as anexperiencedprofessional, are these qualifications and skills:

• Degreeeducatedandpreviousexperience in a similar role

• Hands-on experience withregistration procedures intheregion, such asclinical trials,pre-MAA regulatory procedures(egscientificadvice, orphanapplicationsorPaediatricInvestigation Plans(PIPs)),MA, post-approval changes,extensionsand renewals

• Experience developing regulatory strategies for products in clinical development and post-marketing phases.

• Knowledge ofEUlegislation and regulations relating to medicinal products

• Working with policies, procedures andSOP’s.

• Strong communicationskills - both oral and written.

• Ability toanticipateand prevent potential issues.

• Ability to resolve conflicts and develop a course of action leading to a beneficial outcome.

• Basicproficiencyin using AI tools to support day-to-day work.

THRIVE

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.