募集要項
- 募集背景
- A pioneering pharmaceutical company is looking for a Regulatory Affairs Senior Manager. The selected candidate will work with global teams to define regulatory strategies and manage the submission of regulatory documents.
- 仕事内容
-
A pioneering pharmaceutical company is looking for a Regulatory Affairs Senior Manager.Responsibilities:
* Define development and regulatory strategy with local and global teams
* Lead or support regulatory and CRO activities for specific products
* Provide strategic regulatory advice as a member of global regulatory teams
* Coordinate and respond to regulatory authorities' inquiries within strict deadlines
* Maintain and organise regulatory files per internal standards
* Review and recommend changes to regulatory documentation and processes
Requirements:
* Bachelor's degree or above (advanced science or healthcare degree is a plus)
* More than 5 years of experience in regulatory affairs and clinical development role
* Experience in interpretation of guidelines
* Prior experience with regulatory filings (electronic submissions)
* Knowledge of regulations
* Excellent technical system skills
* Native level Japanese; business level English
- 応募資格
-
- 必須
- More than 5 years of experience in regulatory affairs and clinical development role
- 雇用形態
- Permanent
- 勤務地
- Tokyo
- 年収・給与
- JPY8,000,000.00 - JPY18,000,000.00 per annum
- 休日休暇
- weekends off, public holidays, paid holidays
