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Amgen Regulatory CMC senior manager in Beijing, China

Group Purpose

To facilitate product development by developing and executing the regulatory strategies and effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle.

Job Summary

Regulatory CMC China Manager and Senior Manager is responsible for execution of the China -specific product strategies align with the global strategy. This position prepares and submits NDA/CTD dossiers in collaboration with Global Reg CMC and Operations, and may need support from the local Managers partially. This position provides CMC information of investigational products used in clinical trials to local Dev Ops and external vendors. This position also closely communicates with Regional Reg CMC for registration.

Regulatory CMC China Manager/Senior Manager is also responsible for the following.

  • To manage China RA-CMC group (Senior Manager)

  • To facilitate cross functional (with JAPAC RA-CMC, China RA, China QA etc.) matters

Key Activities

  • Prepare CMC components in NDA dossiers for Amgen products in collaboration with the local Managers, Regional and Global Reg CMC

  • Prepare and update CMC document for CTN in collaboration with Regional and Global Reg CMC

  • Participate in Project Teams and PST as an Local CMC expert

  • Interact with Chinese Health Authorities

  • Provide CMC information for investigational products and medical devices used in clinical trials in China

  • Responsible for LCM for post approval products for variations in strategy, executions, and provide advice to global on the global Operations variation plan.

Knowledge and Skills

  • CMC-specific local regulatory knowledge & experiences

  • Biologics-specific regulatory knowledge & experiences – preferred

  • Communication skills in Chinese and English

  • Team player

  • People management

  • English conversation, read, and writing

  • Computers: Microsoft Outlook/ Word/ Excel/Power Point/Project

Education & Experience (Basic)

  • Over total 10 years’ experience for regulatory CMC and/or CMC (Operation) of pharmaceutical industry including biologics for supporting CDE consultation, NIFDC Quality test submissions, and CTN and NDA submission in China

Education & Experience (Preferred)

Master or Doctor degree

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.