募集要項
- 募集背景
-
Execute assigned regulatory tasks, including securing approvals and certifications, submitting notifications for pharmaceuticals, quasi-drugs, and medical devices in adherence to the PMD Act and pertinent regulations.
Play a key role in broadening the product portfolio.
Additionally, support business sustainability by overseeing license renewals, managing various business licenses, and conducting regulatory reviews of external documents.
- 仕事内容
-
Main Responsibilities:
● Develop regulatory strategies to guide product compliance.
● Handle regulatory submissions for notification, certification, and approval processes.
● Engage in consultations and negotiations with Japanese authorities and prefectural governments.
● Conduct regulatory assessments for change control and management.
● Provide regulatory support for new product and business development initiatives.
- 応募資格
-
- 必須
-
Qualifications & Experience:
● BA/BS degree in a technical or scientific discipline; advanced degree or professional training preferred; Pharmacist license desirable.
● Over 7 years of Regulatory Affairs experience in healthcare with successful submissions and approvals for pharmaceuticals, quasi drugs, medical devices, QMS, and/or foreign manufacturing registration.
● Key skills include leadership, accountability, and project management.
● In-depth knowledge of Japan regulations (including PAL), as well as international regulations such as ISO and IEC.
● Strong scientific and clinical knowledge for understanding technical documents and academic articles.
● Excellent oral and written communication skills in both Japanese and English.
● Business English proficiency in writing and verbal communication.
- 雇用形態
- 正社員
- ポジション・役割
- Senior Specialist - Regulatory Affairs
- 勤務地
- Saitama Prefecture / Chiba Prefecture / Tokyo / Kanagawa Prefecture
- 年収・給与
- 7 million yen ～ 9.49 million yen
