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Job ID :
Location :
Japan - Tokyo
Job Description
  • Handling the discussion and negotiation with PMDA, MHLW and KOLs.
  • Handling the clinical trial with the clinical sites and our business.
  • Handling the GCP (Good Clinical Practice) with the LSG Japan and the clinical sites.
  • Application and communication with the IRBs (Institutional Review Board) at the clinical sites.
  • Handling the submission for IVD/Dx products and preparation of the documents/dossier.
  • Supporting other RA people’s roles such as GVP (Good vigilance practice), Regulatory business silences, Regenerative medicine, CMC, Master File(DMF)and RA training.


  • Required language skills: Fluent in Japanese and business level English (oral and written);
  • Must have a minimum of 5 to 8 years of Regulatory Affairs for In-Vitro Diagnostic/Medical Device and Clinical trials work experience.
  • Experiences and knowledge of Clinical trials, GCP requirements and Submissions.
  • Knowledge of PMDA requirements for In-Vitro Diagnostic/ Medical Device.
  • Great experience of strategies for preparation dossier and submission of In-Vitro Diagnostic/ Medical Device, especially clinical sequencing, oncology, regenerative medicine and advanced medical area.
  • Knowledge of PMDA Import/Export regulations.
  • Direct and positive experience in communicating with PMDA, MHLW and the affected authorities.
  • Multi-site experience, in a large sized company.
  • Requires the ability to provide solutions based on their own knowledge and industry experience base. Some travel is required.
  • A minimum B.Sc. degree in Pharmacology, Biology, Chemistry, bio-engineering or related science. Pharmacist is desired. M.S. or Ph.D. is preferable.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
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