世界をリードする科学サービス企業

Handling the following tasks;

・Discussion and negotiation with PMDA, MHLW.
・Communication with headquarters and Internal Stakeholders.
・Statistical analysis of non-clinical and clinical data, preparation of data package.
・Submission for IVD/MD products and preparation of the documents/dossier.
・Involving portfolio management activities for future products
・Supporting QA activity, involve its Quality Management System and quality policy.

Must be Pharmacist

Required language skills: Fluent in Japanese and business level in English (verbal 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.

勤務地；東京都内
条件；900-1300万円（目安）