RA Associate

Job type Permanent
Salary 5,000,000 - 8,000,000 JPY
Reference 33595


An international diagnostics company that is market leader in IVDs and biomarkers.


Main responsible for supporting regulatory submissions and maintenance of Business Licenses.

  • Supports labelling updates, registration of electronic version of Package Insert in PMDA website and maintenance of UDI in Medical Device Database.

  • Conducts monthly safety management information and maintains electronical submission system.

  • Supports GVP annual training and self-inspection as marketing authorization holder.

  • Supports to prepare required documents for periodic QMS certificate renewal and reimbursement updates for registered product.

  • Supports PMDA consultation

  • Supports preparation of marketing approval application of a new product and maintenance of the registered product in Japan.


  • The company offers competitive salary package

  • They are expanding in Therapeutic Areas soon

  • Fast career progression

  • Office is in Shinagawa, Tokyo

  • Work from home options available


  • At least 3 years of Regulatory Affairs experience in a therapeutics area/IVD/medical device.

  • Basic knowledge of Japanese Pharmaceutical regulatory environment and experience with registration procedures.

  • Ability to organize, review and submit regulatory submission to authorities such as PMDA, MHLW, and local health agency.

  • Experience and knowledge of drug safety.

  • Self-motivated, detail oriented, and able to prioritize and plan effectively

  • BS/MS/RN in related scientific field or equivalent.

  • Proficient in Microsoft Office Suite (Word, Outlook, Excel and PowerPoint).

  • Ability to work independently as well as in a team environment.

  • Business fluent in Japanese and English (speaking and writing)

  • Pharmacist License



  • Click apply


  • Contact Pauline:


050 1742 5298