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| This posting is managed by: | Cornerstone Recruitment Japan K.K. |
|---|---|
| Company Name | Company is not publicly visible |
| Job Type |
 Medical/Pharmaceutical/Bio/Fabric/Food - Other |
| Location |
Asia
Japan
Tokyo
|
| Job Description |
Oversee the application process for CPP requests and GMP compliance inspection applications to PMDA (if applicable). Collaborate with key stakeholders and CMO sites to ensure the timely receipt of GMP certificates. Manage the submission process for GMP requests and GMP compliance inspection applications (if necessary). Work with stakeholders and CMO sites to ensure timely issuance of Manufacturing License (ML) certificates. Supervise the submission process for Manufacturing License requests to PMDA. Coordinate with relevant client departments to gather necessary documents (such as LOAs, declarations, and statements), confirm content (if needed), initiate requests for signatures, and handle notarization, legalization, or apostille procedures (if applicable). Receive and process order requests through the PSS Certificate tool. Obtain required certificates from CMO sites or PMDA and forward them to the requester. Develop and maintain a dashboard for regular updates, highlighting key performance indicators. |
| Company Info | A global leader in providing end-to-end services for the life sciences and pharmaceutical industries, with a focus on regulatory compliance, market access, and supply chain management. |
| Job Requirements |
Strong verbal and written communication abilities, with the capability to present issues clearly and logically. Deep knowledge of relevant topics. Familiarity with statutory documentation. Experience with Japan’s PMDA HA submissions and applications for COPP, GMP, and ML. A degree in science or a related field, with 2–5 years of professional experience. |
| English Level | Fluent (TOEIC 865-) |
| Japanese Level | Native Level |
| Salary | Depends on experience |
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