メディカル・バイオ - 薬事申請

◇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）

■休日：完全週休二日制, 土, 日, 祝日, 年末年始

【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.

■職種未経験者：不可