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キービジュアル キービジュアル
更新日 2018-08-10
掲載開始日 2018-08-10

CMC Sr. Manager

  • ハイクラス
  • ★★★★ マネージャーレベル
この求人の
取扱い会社
人材紹介
Michael Page Japan
企業名 会社名非公開
職種
Michael Page Japan
メディカル/医薬/バイオ/素材/食品 - 臨床開発系
業種 製薬メーカー
勤務地 アジア 日本 東京都

仕事内容 外資バイオ医薬品メーカーでのCMC薬事マネージャーのポジションです。現在、CMC部門にはまだ1名しかおらず、その中で開発製品がかなり多く進んでいるため、活躍の機会は大いにあります。


Description

*All regional regulatory strategic and operational tasks for development products and/or established products from CMC point of view.

*Develops and executes regional CMC strategies, contributes to global CMC regulatory strategies/plans and closely cooperates with Japanese Health Authorities (HA) regarding regulatory dossiers submission, such as new applications and/or partial change application, for development products and/or established products with a view to obtain Japanese HA's approval in the fastest and most efficient way while ensuring compliance with the regional regulatory requirements.

*Preparation of CMC regulatory dossiers for development products and/or established products in accordance with Japanese regulations and requirements.

*Management of negotiations, meetings and consultations with Japanese HAs for development products and/or established products from CMC points of view.

*Interacts with Global Regulatory Leads (GRLs) and other Global Regulatory Affairs Strategy Team (GRAST) members to manage and resolve cross-functional issues.


Profile

Education:
Preferably a post graduate degree in a life science or pharmacy

Experience:
A minimum of 5 years of CMC experience for development products and/or established products, and regulatory activities such as new applications and partial change application. Experience with biological product is desired.

Competencies:
*Proficient in Japanese and English: speaking, listening and writing.
*Strong analytical skills and good judgment for implementing risk-based programs.
*Good communication and presentation skills.
*Good negotiation skills.
*Flexible attitude.


Job Offer

12-15M 基本給、ボーナス、その他福利厚生


応募は、以下の応募ボタンからお願いします。詳細につきましては、Hiroshi Yamaguchiにお問い合わせください+813 6832 8648。
企業について
(社風など)
需要のきわめて高い稀少疾患の治療薬や、大きな承認申請を多くひかえており、その中心となる社会貢献度、注目度の高いポジションです。
応募条件 Education:
Preferably a post graduate degree in a life science or pharmacy

Experience:
A minimum of 5 years of CMC experience for development products and/or established products, and regulatory activities such as new applications and partial change application. Experience with biological product is desired.

Competencies:
*Proficient in Japanese and English: speaking, listening and writing.
*Strong analytical skills and good judgment for implementing risk-based programs.
*Good communication and presentation skills.
*Good negotiation skills.
*Flexible attitude.
英語能力 ビジネス会話 (TOEIC 735-860)
日本語能力 流暢(日本語能力試験1級又はN1)
中国語能力 最低限のコミュニケーション
年収 経験と能力に基づく   
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