Job summary
| Job category | Technical (Sales / Design / Development / Production Control)／Production Control / Quality Control / Construction Control / Environment, Health, and Safety / Postmarketing Surveillance |
|---|---|
| Industry | Health Care／ Medical Equipment |
| Employment type | Uncategorized |
| Position level | Other |
| Number of openings | 1 |
| Desired entry time | - |
| Required language skill |
Japanese （Fluent） English （Business） |
| Foreign language competence | - |
| Working hours | Others |
| Welfares / Leave systems | |
| Assistance in visa application | - |
| Number of foreign employees | - |
Work details
Company Overview
Medical Devices Company
Job Description
• New drug application for approval
• Gap analyses of dossiers provided by overseas sites in comparison with Japanese regulations
• Communication with HAs (negotiations/consultations/meetings)
• GMP application for approval for new drug application/PCA/periodical GMP compliance application
• New application/Renewal of FMA
• Preparation of QA agreement under GQP ordinance
• Manufacture site audit under GQP ordinance
Requirements
Preferable (not mandatory)
• More than 5 years of experience of CMC/Regulatory CMC and more than 2-3 years of experience of QA for pharmaceuticals
• Experiences with MD submission including STED preparation
• Pharmacist
Organizational Knowledge
• Understand the company systems and processes – QA, QC, Marketing, Sales, Customer service, IT, HR, GA, Finance, Manufacturing, Supply chain, Warehouse, Technical Center
• Understand the global culture and different business manner
About interview
Liaison
CMC RA/QA Manager
RGF HR Agent
1000 〜 1200 ten thousand JPY
