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Job ID :
54761BR
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.

REQUIREMENTS / EDUCATION:

  • 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.


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