募集要項
- 仕事内容
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Key activities:
－ Hands on RA responsibilities
－ Attendance of trade association activities, and regional/ global regulations updates
－ QMS submission and foreign manufacturing registration
－ Renewal and maintenance of business licenses （pharmaceuticals, quasi drugs, and medical devices）
－ Document control and information disclosure
－ Development and operation of quality management system in regulatory affairs
－ Clinical development operations such as project lead, progress management, and CRO management for clinical trials
－ Correspondence with Japan authorities related to clinical trials （submission of clinical trial notification, etc.）
－ Knowledge on regulatory requirements and close relationship with Japan Authority.
－ Communication of regulatory requirements and project status with internal stakeholders as necessary.
- 応募資格
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- 必須
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Required:
－ Japan regulation knowledge management, not only PAL but also ISO, IEC, and other related international regulations etc.
－ Scientific and clinical knowledge management to understand technical documents and academic articles, etc.
－ Good oral and written communication skill （Both Japanese and English）
－ Business level of proficiency in English
- 歓迎
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Desired:
－ BA/BS degree in a technical or scientific discipline such as biology, chemistry, physiology, pharmacology, engineering, medical or law. An advanced degree or additional professional training is preferred.
－ A license of Pharmacist is desirable.
- 募集年齢(年齢制限理由)
- チーム構築の為長期勤続を求める募集 （長期勤続によりキャリア形成を図るため）
- 雇用形態
- 正社員
- 勤務地
- 東京都
- 年収・給与
- 700万円 ～ 949万円
