CMC Specialist (Contract) / Global Regulatory Affairs_BioPharma (Tokyo)

Posté 31 déc. 2021

Tokyo, Tokyo - Japan

Demander un identifiant 235052

Détails

A career at our company is an ongoing journey of discovery: our 58,000 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.


 

Work / 業務

Under the instruction, write Module 2 based on the Module 3 privided.  /  指示の元に、モジュール3を元にモジュール2.3を作成する。

Review Moudl 3 / モジュール3のレビュー。
Write the content of AAF (CMC part)医薬品承認申請書のCMCパートの内容の理解及びCMCパートを作成する。

Create, Reivew and QC of ther CMC related documents. / その他、CMC関連資料の作成、レビュー及びQC

Attend meeting if necessary. / 必要に応じ、会議に出席

 

 

Required skilset / Knoldege / 必要な知識、能力

3- 5 years experience in CMC area at pharmaceutical companies / 医薬品業界で3-5年以上のCMC又は、CMC薬事としての業務経験

Read and write English documents / 英語での文書の読書きができる

Understand and Familiar with CMC regulatory notifications including ICH GLs / ICHガイドラインをはじめとするCMC薬事の各種ガイドラインを理解している

Understand the contents of MBR and method SOPs. / マスターバッチレコードや試験施設のSOPの内容の理解。

Able to use basic PC softwares suh as MS office and teams. / 基本的PCソフトが使用できる (MS office, Teams 等)

Team work / チームワークができる

 

30 working hours per week 週30時間勤務
Flexible working sytle is available/在宅勤務や勤務日(日数や一日の勤務時間)については柔軟に対応させて頂きます ※必要に応じて定期体に出社の可能性あり

 

Recruiting Contact: Maiko Yamasue

 

 


What we offer:  With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!

 

Curious? Apply and find more information at https://jobs.vibrantm.com

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