RA Operation & Compliance Manager @ Bio-Pharma Start-up | マイケル・ペイジ・インターナショナル・ジャパン株式会社/Michael Page International Japan K.K.の求人詳細

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キービジュアル キービジュアル
更新日 2022-05-24
掲載開始日 2022-05-24

RA Operation & Compliance Manager @ Bio-Pharma Start-up

  • 人材紹介
  • マネージャーレベル
この求人の
取扱い会社
マイケル・ペイジ・インターナショナル・ジャパン株式会社/Michael Page International Japan K.K.
企業名 会社名非公開
職種
マイケル・ペイジ・インターナショナル・ジャパン株式会社/Michael Page International Japan K.K.
メディカル/医薬/バイオ/素材/食品 - その他
メディカル/医薬/バイオ/素材/食品 - 薬事申請/特許技術関連
業種 製薬メーカー
勤務地 アジア 日本 東京都

仕事内容 Take the lead in the company's IT systems in introducing/maintaining regulatory publishing information, budget management/LRP for the department. Vendor oversight as well as ensuring proper regulatory compliance for operations in Japan.


Description

* Oversee in the management of publishing activities to be delivered according to regulatory submission plan based on Japanese requirements
* Align with global and local strategies in electronic submissions and conversions of eCTD applications
* Work with cross functional departments, global stakeholders to align proper regulatory compliance in ensuring effective procedure
* Be the system owner for Japan business for regulatory information tools and platforms (ex. eCTD publishing tools, EDMS, library system and documentation templates)
* Ensure all tools are correctly implemented, used correctly in accordance to company's SOPs
* Be the point of contact in RA for GxP inspections, investigations to ensure proper CAPAs are implemented.


Profile

* University degree in scientific field (life sciences preferable)
* Work experience in the pharmaceutical/life science field with background in regulatory operations/compliance
* Strong understanding in drug development process as well as experience working with regulatory bodies (PMDA,MHLW, etc)
* Experience in introducing new systems and protocols based on interpretation on regulatory guidelines and mandated legislation like eCTD
* High fluency in English and Japanese (non-native level speakers will not be selected)
* Knowledge in regulatory submissions, review, approval processes


Job Offer

* Competitive salary and benefits
* Great work life balance
* Global start-up environment
* Amazing career progression in regulatory affairs
* Work with industry leaders who are solving unmet patient needs
* Patient-centric focused for new drug development


To apply online please click the 'Apply' button below. For a confidential discussion about this role please contact Zach Itozu on +813 6832 8683.
企業について
(社風など)
* Global bio-pharmaceutical company entered the Japan market as a new start-up organisation
* Dynamic pipeline in new drug development focusing on rare disease for unmet medical needs
* Prides in innovation and patient-centric ideals to deliver 1st in class products
* Exponential growth potential with a business plan to become a key player in Japan
英語能力 ビジネス会話 (TOEIC 735-860)
日本語能力 ネイティヴレベル
年収 日本・円 1000万円 〜 1200万円   
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マイケル・ペイジ・インターナショナル・ジャパン株式会社/Michael Page International Japan K.K.

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