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Updated 2024-04-02
Activated 2024-04-02
Activated 2024-04-02
CMC RA Manager at Global Renown Biopharma
- Recruiter
- Manager Level
| 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 - Patent Medical/Pharmaceutical/Bio/Fabric/Food - Research |
| Industry | Pharmaceuticals |
| Location |
Asia
Japan
Tokyo
|
| Job Description |
Be part of a global renown biopharma with rich development pipeline. Take lead in CMC RA activities to obtain regulatory approval. Description * Take lead in CMC RA activities for the business to obtain regulatory approval of new/existing products * Prepare CTD documents (such as module 3) and other application form for submission * Communicate with health authorities such as the PMDA for consultations and inquiries * Collaborate with global stakeholders to align company strategies * Ensure effective regulatory compliance requirements and guidelines to ensure effective development * Identify any issues from a scientific or technical related areas to avoid any risks Profile * University degree in scientific or related area * High fluency in English and Japanese (non-native level speakers will not be selected) * Extensive CMC RA experience in the pharmaceutical industry * Strong understanding of CMC activities, regulations, and guidelines * Background in drug development process Job Offer * Competitive salaries and benefits * Great work life balance * International environment * Hybrid working style * Amazing career development in CMC RA * Work with industry leaders who are solving unmet medical needs Page Group Japan is acting as an Employment Agency in relation to this vacancy. |
| Company Info |
* One of the top global biopharma companies in the industry * Rich development pipeline specializing in Oncology, Immunology, Immuno-Oncology, Fertility for unmet medical needs * New product launch almost every other year * Extensive communication with global HQ * Hybrid working style |
| English Level | Business Conversation Level (TOEIC 735-860) |
| Japanese Level | Native Level |
| Salary | JPY - Japanese Yen JPY 10000K - JPY 13000K |
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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
