募集要項
- 仕事内容
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Basic Purpose of the Job:
The Head of Development Regulatory Affairs is responsible for developing and implementing regulatory strategies for assigned therapeutic areas. This role includes guiding subordinates on the development of investigational products towards submission and approval and coordinating regulatory maintenance activities in compliance with Japanese regulations. The role requires providing strong leadership and strategic planning to integrate sound regulatory practices into international drug development programs. Additionally, this position involves contributing to staff development in terms of expertise, competencies, and career plans, leading and guiding subordinates, assigning projects, and fulfilling human resource obligations.
- 応募資格
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- 必須
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－ Over 5 years of experience in Regulatory Affairs, including new drug registration.
－ Practical experience with new developments, registrations, and maintenance of Marketing Authorizations.
－ Experience with direct Health Authority interactions.
－ Track record in filings of Clinical Trial Notifications, Marketing Authorization Applications, and related regulatory applications.
－ Over 5 years of management experience.
－ Preferably international work experience.
－ Indepth knowledge of international regulatory requirements and Japanese regulatory legislation.
－ Excellent understanding of internal processes and procedures.
－ Knowledge of drug development, marketing authorization applications, and maintenance.
－ Understanding of health authority environments and trends.
- 歓迎
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Experience:
－ Over 5 years of experience in R＆D and/or medical development.
－ Preferably international work experience.
- 募集年齢(年齢制限理由)
- 長期勤続を図るため （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
- 関東
- 年収・給与
- ～ マックス1600万円トータル給与
- 選考プロセス
- 書類選考＋面接複数回
