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Regulatory Affairs-CMC Exclusive job
| Hiring Company | Global pharma company |
| Location | Tokyo - 23 Wards |
| Job Type | Contract |
| Salary | 6 million yen ~ 8 million yen |
Job Description
Serving as a contact point for the company, coordinates for pharmaceutical affairs matters on product development between internal concerned departments and regulatory authority.
Performs pharmaceutical regulatory affairs tasks for obtaining pharmaceutical product approval. Prepares various pharmaceutical regulatory affairs documents in a timely and appropriate manner according to the product development plan.
Manages pharmaceutical regulatory affairs schedules for product development plan.
Working with internal concerned departments, prepares appendices attached to pharmaceutical regulatory affairs documents to be submitted to regulatory authority and submits them.
Negotiates with subcontractors and external parties about pharmaceutical affairs issues as needed.
Working collaboratively with other departments, reviews the documents (minutes, examination report, etc.) created by regulatory authority, builds a consensus and confirm them with the regulatory authority and obtains the final version of the documents.
Presents pharmaceutical affairs strategies for product development plan to the concerned departments and gains consensus from them.
Support Director’s job
General Requirements
| Minimum Experience Level | Over 3 years |
| Career Level | Mid Career |
| Minimum English Level | Business Level |
| Minimum Japanese Level | Native |
| Minimum Education Level | Bachelor's Degree |
| Visa Status | Permission to work in Japan required |
Required Skills
Minimum 5 years’ work experience in RA.
Job Location
- Tokyo - 23 Wards
Work Conditions
| Job Type | Contract |
| Salary | 6 million yen ~ 8 million yen |
Job Category
- Medical, Pharmaceutical and Healthcare > Production, Factory Manager, QC (Medical)
- Medical, Pharmaceutical and Healthcare > R&D (Others)
Company Details
| Company Type | Large Company (more than 300 employees) - International Company |
| Non-Japanese Ratio | Majority Japanese |
