Biotechnology Regulatory Associate

4 days ago


Hong Kong Island, Hong Kong SAR China Amgen SA Full time

We are seeking a highly skilled Biotechnology Regulatory Associate to join our team at Amgen SA in Hong Kong. As a member of our Regulatory Affairs team, you will play a crucial role in ensuring the successful development, registration, and lifecycle management of our products.

In this role, you will be responsible for creating and reviewing source text for country labeling, coordinating translation for local regulatory submission, and participating in regulatory submissions of urgent safety communications. You will also exchange regulatory information with other teams, provide advice on local regulations, and partner with International Regulatory Leads to support molecule registration.

To succeed, you'll need excellent communication skills in English and Chinese, as well as a strong understanding of regulatory requirements. A Bachelor's degree in a scientific area is required, and regulatory experience in Hong Kong would be an advantage.

We offer a dynamic and supportive work environment, with opportunities to learn and grow with our company. Our Total Rewards Plan includes health, finance and wealth, work/life balance, and career benefits, making us a great place to start or continue your career.



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