Senior Regulatory Affairs Specialist

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