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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 |
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Company Name | Company is not publicly visible |
Job Type |
![]() Medical/Pharmaceutical/Bio/Fabric/Food - Patent |
Industry | Pharmaceuticals |
Location |
Asia
Japan
Tokyo
|
Job Description |
Be part of one of the top global rare disease company in the industry. Take lead in regulatory strategy/development to obtain product approval Description * Take lead in regulatory strategies/development to obtain product approval * As a regulatory lead serve as a contact point for the business between local health authorities (PMDA) * Communicate with global stakeholders to align company strategies from a regulatory point of view * Prepare RA documents to develop product development plan * Lead the submissions * Liaison any local health authority inspections when necessary Profile * University background in scientific or related field * High fluency in English and Japanese (non-native level speakers will not be selected) * Track record of successful product submissions for approval * Well conversed in regulatory documents in the pharmaceutical industry * Ability to negotiate with health authorities as well as global stakeholders Job Offer * Competitive salaries and benefits * Great work life balance * Work with industry leaders who are solving various unmet medical needs * Amazing career progression in RA * Hybrid working style * International working environment * Work with industry leaders who are solving various unmet medical needs 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 pharmaceutical companies specialising in rare disease and orphan drugs * Rich development pipeline including several blockbuster products * Patient-centric organisation for unmet medical needs * Extensive global communication with international working environment * Hybrid working style |
English Level | Business Conversation Level (TOEIC 735-860) |
Japanese Level | Native Level |
Salary | JPY - Japanese Yen JPY 12000K - JPY 16000K |
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