Career Category

Job Description

European Regulatory Affairs ? Clinical Trial Submission Specialist ? Senior Associate (Multiple Positions)

As part of the European Regulatory Affairs Team, Submission Specialists are essential to getting Amgen therapies to patients around the world compliantly, quickly and consistently. We drive strategic, optimal and efficient elaboration of innovative regulatory strategies, collaborate cross-functionally and own the regulatory authority interaction.

We are seeking to hire a submission specialist who is encouraged by Amgen?s science and portfolio, who can support our regulatory team and join us in our mission to serve patients.

Live

What you will do

Let?s do this! Let?s change the world. In this meaningful role you will ensure technical compliance of our Clinical Trial submissions via the smooth compliant flow of information between all functional areas, internal and external to GRAAS, 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. Ensure the technical compliance with EU-CTR 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 CTIS system, 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 EURL to prepare Submission Content Plans and useful documentation for regulatory deliverables, for the management of clinical trials.
• Assist with definition, development, and implementation of processes to meet the evolving CTR needs.
• Raises, informs and resolves any issues that may impact submission process or timelines within CTIS.

Win

What we expect of you

We are all different, yet we all use our outstanding contributions to serve patients. The problem solving Person we seek is a proactive, innovative problem solver and well-organized teammate with these qualifications:

• Master?s degree OR Bachelor?s degree and 2 years of directly related experience.
• Experience in an operationally focused role within Regulatory Affairs and/ or regulatory knowledge related to the region and regulations relating to medicinal products
• Experienced knowledge of the European Clinical Trial Regulation, Clinical Trial processes and EMA CTIS system

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, develop, and move up and across our global organisation.
• 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.

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