Career Category
RegulatoryJob Description
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 Japan Manager is responsible for execution of the Japan-specific product strategies align with the global strategy. This position prepares and submits NDA/CTD/PCA/MCN/consultation dossiers in collaboration with Global Reg CMC and Operations, 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.
Key Activities
- Prepare CMC components in NDA/CTD/PCA/MCN/consultation 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 and PST as an Local CMC expert
- Interact with Japanese Health Authorities
Provide CMC information for investigational products and medical devices used in clinical trials in Japan
To facilitate cross functional (with JAPAC RA-CMC, Japan RA, Japan QA etc) matters
Knowledge and Skills
- CMC-specific local regulatory knowledge & experience
- Biologics-specific regulatory knowledge & experiences
- Chemical products specific regulatory knowledge & experiences
- Communication skills in Japanese and English
- Team player
- 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 PMDA consultation, CTN and NDA submission in Japan
Education & Experience (Preferred)
Master or Doctor degree
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