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Updated 2025-04-02
Activated 2025-04-02
Activated 2025-04-02
Regulatory Certificate Specialist @ Regulatory Consulting
| This posting is managed by: | Michael Page International Japan K.K./マイケル・ペイジ・インターナショナル・ジャパン株式会社 |
|---|---|
| Company Name | Company is not publicly visible |
| Job Type |
 Medical/Pharmaceutical/Bio/Fabric/Food - Manufacturing Technology/Manufacturing Management Medical/Pharmaceutical/Bio/Fabric/Food - Patent |
| Industry | Pharmaceuticals |
| Location |
Asia
Japan
|
| Job Description |
Be part of one of the top global regulatory consulting companies in the industry. Take lead in applications for compliance inspections to obtain licensing. Description * To process the application of the certificate of pharmaceutical product request to PMDA and the GMP compliance inspection application if necesary * Coordination with assigned stakeholders and CMO sites to obtain GMP certificate * To process the application of the GMP request to PMDA and the GMP compliance inspection application (if required) * Coordination with assigned stakeholders and CMO sites for timely obtaining of the manufacturing license certificate * To process the application of a manufacturing license request to PMDA * Receive the certificate from CMO sites or PMDA and process to the client * Prepare a dashboard for periodic communication indicating the key performance Profile * University degree in scientific of related field * High fluency in English and Japanese (non-native level speakers will not be selected) * Knowledge of PMDA and MHLW submission experience for acquiring certificates * Pharmaceutical background Job Offer * Competitive salaries and benefits * Great work life balance * Fully remote option * Amazing career progression in RA pharma * Work with industry leaders who are solving various unmet medical needs * International working environment To apply online please click the 'Apply' button below. For a confidential discussion about this role please contact Saki Kanematsu at +81 3 6832 8904. |
| Company Info |
* Global Regulatory/Quality consulting company specialising in the pharmaceutical, medical device, cosmetic areas * Rich project pipeline working with some of the top health care companies in the industry to support in regulatory and quality activities * Japan business grew exponentially within the past 5 years due to demand * Fully remote * International environment with extensive global collaboration |
| English Level | Daily Conversation Level (TOEIC 475-730) |
| Japanese Level | Native Level |
| Salary | JPY - Japanese Yen JPY 8000K - JPY 10000K |
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Recruiter
Michael Page International Japan K.K./マイケル・ペイジ・インターナショナル・ジャパン株式会社
