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Updated 2025-03-07
Activated 2025-03-07

RA Development Strategy Director at Top Global Pharma

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
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
Medical/Pharmaceutical/Bio/Fabric/Food - Other
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   
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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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