募集要項
- 募集背景
- A multinational company in the pharmaceutical industry is searching for a Regulatory Affairs Staff to be based in Osaka. In this role you will ensure successful filings and renewals with PMDA, communicate regulatory requirements to various areas of the company, and provide clients with technical documents.
- 仕事内容
-
A multinational company in the pharmaceutical industry is searching for a Regulatory Affairs Staff to be based in Osaka.Responsibilities:
* Coordinate the submission procedure for each product
* Identify, describe, and control changes in the product files
* Provide clients with technical support in the regulatory area
* Lead training sessions on regulatory affairs-related subjects
Requirements:
* Bachelor's degree in Pharmaceutical Sciences, Chemistry, or Natural Sciences
* 5+ years' experience in regulatory affairs, preferably related to active pharmaceutical ingredients
* Knowledge of submission procedures in Japan
* Ability and willingness to travel in Japan and occasionally overseas
* Verbal and written proficiency in English and Japanese
- 応募資格
-
- 必須
- 5+ years' experience in regulatory affairs, preferably related to active pharmaceutical ingredients
- 歓迎
- 英語力必要。その他は詳細からご確認ください。
- 雇用形態
- Permanent
- 勤務地
- Osaka
- 年収・給与
- Up to JPY7000000 per annum
- 休日休暇
- 完全週休2日制, 土日祝日休み, 有給休暇