Regulatory Affairs Manager, Head Pharmacist

23時間前

Tokyo Guerbet Long-term/regular

Description

1. General Marketing Compliance Officer (SOKATSU-SEKININSHA)

Responsible to assure compliance with GVP and GQP through supervision and instruction to safety manager and quality assurance manager. Must report issues and risks to the MAH. Name and address are registered with government agencies as contact point for GVP/GQP related matters.

2. Regulatory Affairs Regulatory Affair (RA)

  • Is the contact person dealing with the authorities for RA in Japan.
  • Checks the legal and regulatory compliance as well as the scientific content of the documentation sent by the Corporate RA department. Submits variations, renewals or new marketing authorization applications to competent authority. Attaches any relevant documentation according to the local requirements.
  • Is in charge of the follow-up of the pending approvals. Answers questions and provides additional documentation when requested by the authority. Informs the Corporate RA department about the approval status of the dossiers.
  • Is in charge of the local regulatory intelligence. Informs the Corporate RA department about new regulations in Japan.
  • Proposes regulatory strategies based on expertise and knowledge of the Japanese laws about medicines.
  • Revises and validates the texts of the packaging materials and SmPCs of the products.

    • Education, Background

  • Pharmacist license in Japan. (mandatory as stiplulated by law)
  • Extensive knowledge of GVP and GQP for prescription drugs
  • Fluent in Japanese.
  • Business Level English (TOEIC> 800).

    • Reason to join US

    Much more than a Competitive salary,

    We offer continued personal development. When you join Guerbet, you :

  • Are choosing a global leader with recognized expertise in diagnostic and interventional imaging,
  • Are joining our 2820 collaborators who are committed every day to offering innovative solutions to improve quality of patient's life all over the world,
  • Are joining a company where we value diversity of talents coming from various horizon.

    • We # Innovate # Cooperate # Care #Achieve at Guerbet.

    or you can also call this number

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