IVD Regulatory Affairs

場所: Tokyo 23 wards, Japan
給与: ¥7000000 - ¥8000000 per annum + bonus
業種: 薬事申請
職種: 正社員


New IVD products in Japan. Seeking RA candidates to support portfolio expansion.

<Client Overview>

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

To find out more about Real Staffing, please visit www.apac.realstaffing.com

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