Career Category

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

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.

EU CLINICAL TRIAL SUBMISSION SPECIALIST – SENIOR ASSOCIATE

LIVE

What you will do

In this vital role you will ensure technical compliance of our Clinical Trial submissions via the smooth compliant flow of information between all functional areas, local offices, external partners and regulatory authorities.

• You will be assigned to one or more Amgen products under development to ensure Clinical Trial Application approvals in the EU. As technical experts in the EMA Clinical Trial Information System (CTIS), ensure compliance with EU Clinical Trials Regulation for every Clinical Trial submission dossier through close internal cross-functional collaboration.
• Be the operational driver for Clinical Trial Submissions and Notifications in the state-of-the-art Regulatory Document Management System and maintain tracking systems.
• Be the critical technical coordinator for Clinical Trial Submissions and Notifications through the EMA Clinical Trial Information System (CTIS), ensuring accurate and timely input of data into the EMA CTIS system for Clinical Trial Applications, Modifications and Notifications.
• Be responsible for reviewing and triaging of Requests for Information from Health Authorities through CTIS to relevant cross functional teams.
• Support the EU Regulatory Lead to prepare Submission Content Plans and documentation for regulatory deliverables, for the management of Clinical Trials.
• Assist with definition, development, and implementation of processes to meet the evolving CTIS needs.
• Raises, informs and resolves any issues that may impact submission process or timelines within CTIS.

Be part of our team

You would be joining the EUMEA Submission Management Team, part of the Global Regulatory Operations function. We work as a regional team providing support and technical advice, and where required contribution to planning, management and submission of technically compliant dossiers to European, Middle East and African Health Authorities. The EUMEA Submission Management work in cross functional partnerships to ensure seamless end to end management of European, Middle East and African filings.

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:

• Experience in an operationally focused role within Regulatory Affairs
• Knowledge of the drug development processes, Regulatory Affairs and Submission Management
• Knowledge and proven execution of CTA Processes in EU, comprehensive understanding of the EU Clinical Trials Regulation, EU Clinical Trials Directive and ICH/GCP

• Ability to quickly learn new software, regulations and processes
• Proactive, innovative problem solver and well-organized teammate

• Master’s degree OR Bachelor’s degree and proven directly related experience.

THRIVE

What you can expect of us

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

• Vast opportunities to learn and move up and across our global organization
• Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
• Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

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, 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 essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.