Career Category

Regulatory

Job Description

Join our team at AMGEN Capability Center Portugal, number 1 company in Best WorkplacesTM https://www.greatplacetowork.pt/ ranking in Portugal in 2024 (category 201-500 employees) by the Great Place to Work Institute. We have a team of over 500 talented people and more than 40 different nationalities, diverse areas of expertise and professional experience that are shaping the future of healthcare. This is your chance to explore a world of opportunities in different areas such as Cybersecurity, Data & Analytics, Digital, Technology and Innovation, Finance, General & Admin, Human Resources, Regulatory Affairs and many more. In Lisbon's city center, our AMGEN office fosters innovation, excellence, and inspiration. Come thrive with us at AMGEN, supporting our mission To Serve Patients. What we do at AMGEN matters in people’s lives.

SENIOR ASSOCIATE REGULATORY AFFAIRS

Amgen's Regional Regulatory Affairs team offers European regulatory leadership and execution across the development, registration, and lifecycle management of all Amgen molecules. The team thrives on innovation and collaborates cross-functionally to advance product strategies through regulatory authority interactions. Our team is seeking a motivated regulatory professional, inspired by Amgen’s science, to support our mission of serving patients.

LIVE

WHAT YOU WILL DO

Let’s do this. Let’s change the world. In this vital role you will be assigned to one or more Amgen products and may support a Regional Regulatory Lead (RRL) or lead a program under the supervision of an experienced regulatory lead.

Key Responsibilities:

• Execute the EU regulatory strategy and EU regulatory plans.

• Prepare supportive documentation for regulatory deliverables, including the management of clinical trial applications, marketing authorizations, and lifecycle management activities.

• Use of Amgen systems and document management.

• Ensure and support regulatory product compliance.

• Work with policies and SOPs.

• Build effective relationships and communication paths across local and functional organizations.

• Enable efficiencies and seamless execution across the region countries.

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, autonomous and collaborative professional, with these qualifications and skills:

Minimum Requirements

• Master’s degree or Bachelor’s degree (scientific area) and 3 years of directly related experience.

• Demonstrated experience in clinical trial regulatory affairs.

• Previous experience in developing and maintaining CTA documentation in Europe (e.g. IMPDs, IMPD amendments) is ideal.

• Depth knowledge of EU legislation and regulations relating to medicinal products is ideal.

• Adaptability and strong English communication skills, both oral and written.

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.

APPLY NOW

Objects in your future are closer than they appear. Join us.

CAREERS.AMGEN.COM

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.

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