募集要項
- 募集背景
- A luxury cosmetics retailer and manufacturer is in need of a Regulatory Affairs Manager. This position will support regulatory compliance, and manage external parties. This is a great opportunity advance your career in compliance with a widely respected company.
- 仕事内容
-
A luxury cosmetics retailer and manufacturer is in need of a Regulatory Affairs Manager.Responsibilities:
* Ensure compliance of all market products sold in the country via drug registration, raw material assessment, PMDA inquiry management, licence renewal regulatory audits, advertising copy approval, etc.
* Adhere to GQP and GVP regulations
* Provide relevant consultation and training to clarify regulatory requirements and promote risk managements throughout all departments of the company
* Cooperate with other teams to conduct issue management such as product recalls, negotiation with regulatory authorities, and communication strategies
* Cooperate with cosmetic industrial associations and Global regulatory affairs teams to be informed of upcoming regulatory information
Requirements:
* Bachelor's degree in pharmaceutical sciences or chemistry
* Regulatory affairs experience in a relevant industry
* Detailed understanding of drug and medical device law and regulations
* Customer relationship management skills
* Ability and willingness to travel within the APAC region about once a year
* Native level Japanese; business level English
- 応募資格
-
- 必須
- Regulatory affairs experience in a relevant industry
- 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
- Tokyo
- 年収・給与
- JPY7,000,000.00 - JPY13,000,000.00 per annum
- 休日休暇
- 完全週休2日制, 土日祝日休み, 有給休暇
