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    Senior Regulatory Affairs Specialist - Tokyo, 日本 - Coty

    Coty
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    説明

    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.
  • ( 3 0%) 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

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