募集要項
- 募集背景
- A luxury cosmetics good company is looking to hire a Regulatory Affairs Senior Coordinator. This position will be responsible for regulatory risk management and compliance, regulatory support for brand business, interaction with internal stakeholders, and network building in the APAC region.
- 仕事内容
-
A luxury cosmetics good company is looking to hire a Regulatory Affairs Senior Coordinator.Responsibilities:
* Manage audits for licence renewals and supervise junior staff for renewal of accreditation of foreign quasi-drug manufacturers
* Ensure compliance with GVP and GQP by cooperating with dermatologists and global safety experts
* Ensure regulatory compliance for product formulas, raw materials, and product labels etc. by carrying out product registration, developing a registration dossier, regulatory risk consultation, and assessment of copy claims
* Ensure compliance to pharmaceutical laws and regulations including fire defence laws for hazardous materials
* Manage relationships and compliance with the PMDA, Tokyo Metropolitan Government, and cosmetic industrial associations
* Cooperate with global APAC regulatory affairs team and represent the country at the APAC regulatory affairs summit
Requirements:
* Bachelor's degree in pharmaceutical sciences or chemistry
* Regulatory affairs experience in cosmetics
* Customer relationship management ability
* Ability and willingness to travel within the APAC region approximately once a year
* Business level English
- 応募資格
-
- 必須
- Regulatory affairs experience in cosmetics
- 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
- JPY4,500,000.00 - JPY6,000,000.00 per annum
- 休日休暇
- 完全週休2日制, 土日祝日休み, 有給休暇
