Senior Associate Regulatory Affairs (1-year fixed-term contract) in Lisbon, Portugal
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, Information Systems, 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. Our ACCP brand-new offices are located in Sete Rios, in the vibrant city center of Lisbon. 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.
Senior Associate Regulatory Affairs (1-year fixed-term contract)
Live WHAT YOU WILL DO
Regional Regulatory Affairs provides European regional regulatory leadership/expertise and execution for the development, registration, and lifecycle management of all Amgen molecules. We are a team of regulatory professionals who thrive on the challenge and opportunity that leading innovative regulatory challenges provides. Together, we in the regulatory team collaborate cross-functionally to optimally develop Amgen products, leading the regulatory authority interactions to effectively drive our product strategies. 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. Responsibilities include:
Execute the regional regulatory strategy and regional 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.
The energetic professional we seek is a collaborative and communicative person with these qualifications:
Required education:
Master's degree (scientific area) OR Bachelor's degree (scientific area) and 2 years of directly related experience.
Preferred knowledge:
Degree and in-depth regulatory experience and/or related to the region.
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