募集要項
- 募集背景
- 欠員補充
- 仕事内容
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To leverage your expertise in regulations governing drug development to advance our portfolio.- Responsible for tasks as Japan Regulatory Scientist on assigned projects.
- Prepare and implement Japan regulatory strategic and operational plans for development products and lifecycle management (LCM) in alignment with global regulatory strategies with support from the Regulatory Science Lead.
- Prepare and review regulatory submission documents, PMDA briefing documents, CTN documents, and response documents.
- Ensure the quality of regulatory documents according to quality standards and manage quality regulatory submissions.
- Provide strategic and operational regulatory input and guidance in cross-functional teams.
- Build effective relationships with regulatory agencies and external parties (PMDA/MHLW/Academia/Industry associations).
- Work flexibly to provide broad operational support to ensure the delivery of business objectives.
- 応募資格
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- 必須
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- Bachelor's Degree/master’s degree (preferable).
- Thorough understanding of Japanese regulations and regulatory procedures.
- Review skills for regulatory documents.
- Ability to communicate and give presentations in English and Japanese.
- Ability to manage and communicate well with other RA staff, other functions, and CROs.
- Ability to build and manage effective relationships with regulatory agencies.
- Flexibility and adaptability to decide actions based on the situation, change behavior or approach to fit the situation or the person, and work effectively in ambiguous situations.
- Ability to lead an assigned cross-functional team to achieve key outcomes within agreed timelines.
- 募集年齢(年齢制限理由)
- 長期勤続によりキャリア形成を図る為 （長期勤続によりキャリア形成を図るため）
- フィットする人物像
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こんな方なら向いている
― グローバル及び日本で両方基盤がしかっりした外資バイオベンチャーにおいて申請業務をリードしたい方
ー バイオ製品に特化し、中枢神経系疾患及び免疫疾患領域での申請業務をやりたい方
ー 階級に厳しくなく、フラットな組織で幅広い守備範囲で業務に携わりたい方
- 雇用形態
- 正社員
- ポジション・役割
- Regulatory Scientist
- 勤務地
- 埼玉県 / 千葉県 / 東京都 / 神奈川県
- 年収・給与
- マックス1500万円トータル給与（具体システムは要相談）
- 選考プロセス
- 面接複数回
