Job ID :
Japan - Tokyo
- 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.