IVD Regulatory Affairs
New IVD products in Japan. Seeking RA candidates to support portfolio expansion.
Gaishikei company established in Japan and expanding their product offering.
- Preparation of regulatory submission dossier, responding to inquiries / meetings with PMDA / MHLW / MAFF.
- Communication with pharmaceutical companies, academia, KOLs, etc.
- Communication with Global related departments
- Registration / maintenance of qualification survey for DMF (master file) and PMDA certificates
- CMC consultation/documentation for regenerative medicine, cell therapy, and biologics products.
- Native level Japanese
- Basic or above English
- RA experience
Real Staffingについてもっと詳しく知りたい方はこちらへ→ www.apac.realstaffing.com/ja