Job ID :
Japan - Tokyo
- Handling the discussion and negotiation with PMDA, MHLW.
- Handling the communication with headquarters (Uppsala, Freiburg).
- Handling the communication with Internal Stakeholders.
- Handling the statistical analysis of non-clinical and clinical data, preparation of data package.
- Handling the submission for IVD/MD products and preparation of the documents/dossier.
- Involving portfolio management activities for future products of TFD KK
- Supporting QA activity of TFD KK, involve its Quality Management System and quality policy.
REQUIREMENTS / EDUCATION:
- Must be pharmacist
- Required language skills: Fluent in Japanese and business level in English (oral and written)
- Must have an experience of Regulatory Affairs for In-Vitro Diagnostic/Medical Device for a minimum of 5 years.
- Experiences of consultation, discussion and negotiation with PMDA through consultation, application for marketing approval and partial change approval.
- Experiences of reimbursement process for clinical test, negotiation with MHLW.
- Knowledge of Pharmaceuticals & Medical Devises Act., QMS ministerial ordinance.
- Experiences of QA activities for In-Vitro Diagnostic/Medical Device. QMS compliance inspection, Internal Audit, Field Safety notice and Recall
- Experiences of QMS supervisor is desired.