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Regulatory Affairs Manager at innovative global pharma
| Hiring Company | Global Pharmaceutical Company |
| Location | Tokyo - 23 Wards |
| Job Type | Permanent Full-time |
| Salary | 8 million yen ~ 15 million yen |
Work Style
Remote Work and WFH Flex TimeJob Description
Develop and execute regulatory affairs (RA) activities from the development to the life cycle management, with collaborative with global and Japan stakeholders.
Key Responsibilities:
Lead regulatory affairs interactions with Health Authorities (HAs)
Oversee New Drug Application (NDA) and supplemental NDA (sNDA) submissions
Manage Japan NDA preparation and support Health Authority review for approval
Prepare regulatory components of the Japan CTD, including the Approval Application Form and Module 1
Lead the development and maintenance of electronic Japanese Package Inserts (J-PI)
Serve as the Regulatory Affairs representative for SOP/Work Instruction updates and process improvement initiatives
General Requirements
| Minimum Experience Level | Over 6 years |
| Career Level | Mid Career |
| Minimum English Level | Fluent |
| Minimum Japanese Level | Native |
| Minimum Education Level | Bachelor's Degree |
| Visa Status | Permission to work in Japan required |
Required Skills
Experience in Research & Development, particularly in Regulatory Affairs
Proven track record of collaboration with cross-functional teams and global stakeholders
Native-level Japanese and Advanced English
Strong stakeholder management skills
Job Location
- Tokyo - 23 Wards
Work Conditions
| Job Type | Permanent Full-time |
| Salary | 8 million yen ~ 15 million yen |
| Industry | Pharmaceutical |
Job Category
- Legal, General Affairs and Public Relations > Legal, Compliance
- Legal, General Affairs and Public Relations > Other (Legal, General Affairs and PR)
- Medical, Pharmaceutical and Healthcare > Other (Medical, Pharmaceutical and Healthcare)
Company Details
| Company Type | Large Company (more than 300 employees) - International Company |
