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.

Regulatory Affairs Senior Associate

Location: Hong Kong

LIVE

What you will do

The Local Regulatory Representative (Sr. Associate) is assigned to one or more Amgen products and may support an LRR or lead a program under the supervision of an experienced Local Regulatory Lead. The product(s) assigned have low/medium complexity programs/strategies and medium impact to Amgen.

• Assist in aligning local regulatory requirements with Amgen’s corporate standards.
• Provide national/regional (as applicable) input to and execute regulatory strategies.
• Plan and manage local regulatory submissions in compliance with corporate standards and local regulatory requirements.
• Ensure local labels are developed and maintained in line with local legislation and Amgen standards and procedures.
• Act as the point of contact with regulatory agencies.

WIN

What we expect of you

• Master’s degree (scientific area) OR  Bachelor’s degree (scientific area) and 2 years of directly related experience
• In-depth regulatory experience and/or related to the country(ies).
• Depth knowledge of country(ies) legislation and regulations relating to medicinal products.
• Knowledge of Regulatory principles.
• Working with policies, procedures and SOP’s.
• Comprehensive understanding of regulatory activities and how they impact other projects and/or processes.
• General knowledge of national legislation and regulations relating to medicinal products.
• Understanding of drug development.
• Demonstrate ability to work in teams.
• Ability to understand and communicate scientific/clinical information.

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.