Amgen Regulatory CMC Manager in Tokyo, Japan
Regulatory CMC Japan Manager is responsible for execution of the Japan-specific product strategies align with the global strategy. This position prepares and submits NDA/CTD dossiers in collaboration with Regional Reg CMC, and may need support from the local Senior Manager 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 Japan local regulation and requirement.
Prepare CMC components in NDA dossiers for Amgen products in collaboration with the Senior Manager, Regional and Global Reg CMC
Prepare and update CMC document for CTN in collaboration with Regional and Global Reg CMC
Participate in Project Teams as an Local CMC expert
Interact with Japanese Health Authorities
Provide CMC information for investigational products used in clinical trials in Japan
Prepare documents for GMP inspection in collaboration with local QA
Knowledge and Skills
CMC-specific local regulatory knowledge & experience
Biologics-specific regulatory knowledge & experiences – preferred
Communication skills in Japanese and English
English conversation, read, and writing
Computers: Microsoft Outlook/ Word/ Excel/Power Point/Project
Education & Experience
- Over total 7 years’ experience for regulatory CMC and/or CMC (Operation) of pharmaceutical industry including biologics for supporting PMDA consultation, CTN and NDA submission in Japan
Education & Experience (Preferred)
- Master or Doctor degree
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.