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Job Description

HOW MIGHT YOU DEFY IMAGINATION?

The Amgen Capability Center in Lisbon, Portugal (ACCP) will be home to over 300 multi-national and multi-cultural employees, representing a broad range of cross functional capabilities, including Commercial, General and Administrative, Research and Development and more. The ACCP will offer rich career growth and development opportunities, regional and global exposure and the opportunity to LIVE, WIN and THRIVE in one of Europe’s most attractive cities.

The ACCP will be temporarily located at the Maleo – Saldanha, Av. da República 18, 1050-191 Lisbon. We’re already gearing up to have our brand-new permanent office ready in the vibrant city center of Lisbon by the spring of 2022.

If you feel like you’re part of something bigger, it’s because you are. At Amgen our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of. Join us.

eCTD Submission Specialist - Senior Associate

As part of the Global Execution team, Global Submission Management is essential to getting Amgen therapies to patients around the world compliantly, quickly and consistently. We drive strategic, optimal and efficient execution of innovative regulatory strategies.

LIVE

What you will do

Let’s do this. Let’s change the world. In this vital role you will ensure technical compliance of our submissions via the smooth compliant flow of information between all functional areas, internal and external to GRAAS, local offices, external partners and regulatory authorities.

• Manage and deliver the technical compliance of every submission every time.
• Lead the publishing of regulatory submissions through detailed planning and delivery of compliant regulatory submission components and product dossiers.
• Maintain state-of-the-art regulatory document management systems and tracking systems.
• Interpret and analyze evolving technical standards and submission processes to ensure we continuously improve how we operate.

WIN

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The problem solving professional we seek is a proactive, innovative thinker and well-organized team player with these qualifications:

Education:

• Master’s degree OR Bachelor’s degree and 2 years of directly related experience.

Preferred knowledge:

• Experience in an operationally focused role within Regulatory Affairs
• Experience of the publishing of global Clinical Trial and Marketing Applications
• Strong knowledge of eCTD, eCTD Specifications and eCTD software

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.

APPLY NOW

for a career that defies imagination

In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.

careers.amgen.com

EQUAL OPPORTUNITY STATEMENT

Amgen is an Equal Opportunity employer and will consider you without regard to your race, colour, 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 essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.