※Applicants must have permission to work in Japan and required fluent ~ native level Japanese.
Responsible for Regulatory CMC life cycle management (LCM) for commercial products (Biologics, Antisense oligos and Small Molecules) for delivering our high quality products to Japanese patients; Regulatory management of global change control strategy for Japan, including change control assessment and execution, i.e. preparation of PCAs. MCNs tight relationships with global regulatory CMC team and/or Japan QAQC, Supply chain. Japanese new drug application submission support
These are executed under tight relationships with not only Global regulatory CMC team, but Japan QAQC and/or Supply Chain.
- To prepare, submit/notify PCA/MCN at appropriate timing
- To manage/respond against inquiry from PMDA and make answers with global regulatory CMC team under tight relationship for getting approval
- To manage/assess global change control for commercial products under Japanese regulation and to create regulatory submission strategy
- To compare/confirm between M1.2 ENG, JPN and/or actual from the point of RA-CMC's view
- To prepare/submit GMP compliance inspection request/FMA application to PMDA under cooperation with Japan QAQC and global Reg CMC team
- To prepare and deliver effective external presentations.
- To support the expansion of our portfolio in Japan by supporting J-NDA submission activity and staying current with information about early phase drug development candidates of Japan portfolio.
- To support Sales for providing the answer to the question from hospital/pharmacy about CMC-related matters.
- To check/input to global Reg CMC/JPN PO&T team about Japanese regulation update
- More than 5yr experience and knowledge in CMC fields
- Demonstrated experience for PCA/MCN and negotiations with PMDA
※Experiences and skills will be considered
Please click "apply" if you are interested in the job.
We will review your profile and contact you within five business days should we find that you satisfy the requirements of the hiring company.
Further details about the company and position will be notified at a later date.