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Updated 2025-03-18
Activated 2025-03-18
Activated 2025-03-18
Regulatory Affairs Manager at Global Leading Biopharma
| 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 - Other |
| Industry | Pharmaceuticals |
| Location |
Asia
Japan
Tokyo
|
| Job Description |
Take lead in RA activities to obtain new product approval. Manage partial change application. Description * Take lead in RA activities to obtain new product approval * Manage partial change application * Lead in NDA submission, CTD documents for Module 1 * Manage any partial change application or minor change notification * Communicate with global stakeholders to align regulatory strategy and development Profile * University degree in scientific or related environment * High fluency in English and Japanese (non-native level speakers will not be selected) * Extensive RA development experience in a pharmaceutical environment * Ability work cross-functionally as well as communicate with global stakeholders Job Offer * Competitive salaries and benefits * International working environment * Amazing career progression in RA * Work with industry leaders who are solving unmet medical needs * Hybrid working style 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 |
* One of the top global biopharma companies in the industry * Specializing in oncology, immunology, immuno-oncology, and fertility * Rich development pipeline with extensive patient-centric focused products/therapies * Hybrid working style * International working environment |
| English Level | Business Conversation Level (TOEIC 735-860) |
| Japanese Level | Native Level |
| Salary | JPY - Japanese Yen JPY 10000K - JPY 15000K |
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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
