CMC RA/QA Manager

Location: Japan - Tokyo
Job Type: 正社員
Salary: 10000000 - 12000000 JPY
Job Function: Chemistry & Manufacturing Controls (CMC)
Reference: JO-200608-219200
Industry: Life Sciences & Healthcare
Sub-Industry: Medical Devices

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