職位記述書
職務名
薬事規制スタッフ
勤務地
東京本社
レポート先
Quality, Safety & Regulatory Manager
担当ディビジョン
Consumer Beauty & Luxury /Rimmel, Gucci, Burberry, CK, Tiffany,etc.
雇用形態
正社員 (full time)
業務内容
化粧品製造販売業者コティジャパンの薬事業務の遂行
主要業務
- (70%) コティジャパン薬事規制業務
- マーケティングおよび R&D と協力し、製品の成分、製品訴求、および製品表示が日本の規制に適合している事の確認
- 化粧品の申請書類作成・申請業務
- 化粧品の届出業務
- (30%) 安全管理責任者（安責）業務
- GVPの順守・運用・維持
- 有害事象（皮膚クレーム等）の対応
採用理由
新規ブランド導入による業務範囲拡大の為
応募資格
薬学・化学の学位
化粧品の申請業務経験
より好ましい条件
輸入化粧品会社での医薬部外品申請業務経験
Position Description
Position Title
Regulatory Affairs Specialist
Location
Tokyo HQs
Reports to
Quality, Safety & Regulatory Manager
Scope / Brands
Consumer Beauty & Luxury /Rimmel, Gucci, Burberry, CK, Tiffany,etc.
Employ type
Permanent (full time)
Position’s Mission
Ensure that Coty Japan operates within Japan regulatory and safety regulations
Essential Functions
- Coty Japan Regulatory Affairs. Mainly carry out application work for cosmetics
- Perform the duties of Safety Control Manager for Coty Japan. 安全管理責任者（安責）
Key Role & Responsibilities
(70%) Coty Japan Regulatory Affairs.
- Collaborates with Marketing and R&D to ensure that product ingredients, claims and artwork complies with Japanese regulations.
- Preparation and application of application documents for quasi-drugs
- Collect relevant information and register foreign manufacturer with authorities.
- Submit cosmetics product notifications to the authorities.
(30%) Perform the duties of Safety Control Manager for Coty Japan. 安全管理責任者（安責）
- Report adverse health events (vigilance reporting) to PMDA and collect of safety management information.
- Monitor the safe use of the product in Japan and track any safety-related events in the markets where the products are being and have been sold.
- Maintain and ensure compliance with GVP SOPs.
- Send notifications to the GMM in a timely manner
Other special requirement for the position
- Experience in application work for cosmetics
- High level interpersonal skills with ability to work collaboratively with other functional teams
- Ability to positively influence decision makers at different levels.
- Ensure all activities comply with Coty policies and legal and ethical standards
It is more preferable if the following conditions are met
- Previous experience in foreign cosmetics company.
- Business level Japanese & English communication
Please continue with your application
or
By signing in to your account, you agree to Bestjobs.jp's Terms of Service and consent to our Privacy Policy.
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
Save now, apply later
or
By signing in to your account, you agree to Bestjobs.jp's Terms of Service and consent to our Privacy Policy.
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
