Regulatory
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.
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.
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
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
Master or Doctor degree
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