Regulatory Affairs Senior Specialist

【求人No NJB2316846】
◇主な担当業務：

・As person in charge of overseas regulatory affairs in Japan Regulatory Affairs work with APAC Regulatory Affairs member and lead to prepare documents for registration in export markets
・Provide regulatory related support for product development marketing supply chain and other departments for export.
・Conduct regulatory review and approval on product formulas claims labels and promotional materials for domestic and export.
・Monitor new or amendment of regulations and update business partners as necessary and ensure products are compliance to changes of regulations.
・Maintenance and renewal work for product and JP marketing licenses for cosmetic/quasi drug.

◇主なStakeholders（主に協働する部署、担当者）

As below with the expected order of communication frequency （Primary language for communication）
Direct supervisor （Japanese）
Team members （Japanese）
APAC Regulatory Affairs members （English）
Marketing member （English/Japanese）
Members in other related function （Japanese/English）
International interactions

Meeting（Online/In person）
Mail/Chat
Business trip（1～2/yr）

◇海外との関わり合い/英語の使用頻度

上記担当業務の遂行およびstakeholdersとの関わりにおいて英語を使用する機会が多い。（メール、電話会議、資料作成、社内システム）

【必須 Must have】
・B.S or M.S education background in Chemistry Pharmaceutical Science etc.
・6+ year working experience in cosmetic and/or quasi drug registration especially overseas regulatory affairs.
・Experience in hair related cosmetic/quasi drugs notification/registration or development preferable
・Business level English skills
・Lead and manage the project actively.