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 read over 10 million patients worldwide. The Regulatory Affairs (RA) Team in the Swiss Affiliate is looking for a Senior Associate Regulatory Affairs 80-100%. It’s time for a career you can be proud of. Join us.

Senior Associate Regulatory Affairs 80-100% (Swiss Affiliate)

LIVE 

What you will do 

Let’s do this. Let’s change the world. In this business critical role you will provide expertise and execution for the development, registration, and lifecycle management of all Amgen molecules.

• Local coordination and execution of regulatory submissions to Swissmedic in compliance with corporate standards and local regulatory requirements (Verordnung über klinische Versuche in der Humanforschung Vklin, Arzneimittelzulassungsverordnung AMZV)
• Management and execution of the preparation, delivery and electronic archiving of documentation for inclusion in local regulatory clinical trial submissions to Swissmedic
• Ensure regulatory clinical trial submissions to Swissmedic are made on time and meet Amgen’s corporate and local regulatory requirements in Switzerland
• Coordination and execution of RA processes and deliverables in the local office
• Under general supervision participates in regulatory activities to ensure effective Swissmedic interactions
• Act as a contact where appropriate with Swissmedic in fulfilling local obligations by project assignment

WIN 

What we expect of you 

We are all different, yet we all use our unique contributions to serve patients. The flexible yet precisely working professional we seek is a strong communicator with these qualifications.  

Basic Qualifications:

• You posses a Bachelor’s degree in a science discipline and 2 years of directly related experience
• You are fluent in German and English, both written and spoken
• Ability to understand and communicate scientific/clinical information
• Strong communication and organizational skills
• Ability to recognize and escalate potential issues
• Attention to detail

Preferred Qualifications:

• Fluency in French
• Ideally you are used to working in a regulated environment 
• Experience with document management and archiving practices

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