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RA Manager/Senior Manager (Hybrid/Remote)

Job Description - RA Manager/Senior Manager (Hybrid/Remote)




  • Lead regulatory strategy for new drug development and approval in Japan

  • Manage PMDA consultations, submissions, and regulatory communications

  • Prepare and review CTD dossiers and approval application documents

  • Coordinate with global and cross-functional teams on regulatory activities

  • Strong knowledge of Japanese pharmaceutical regulations and clinical trial requirements






Requirements

  • 4+ years of experience in regulatory affairs within the pharmaceutical industry





  • Benefits




    • Gain hands-on experience leading regulatory strategy and PMDA consultations for innovative new drug projects in Japan.

    • The role also offers strong exposure to cross-functional leadership and career growth into broader regulatory responsibilities.




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    About the Company

    Morunda K.k.

    Morunda specialises in executive recruitment for pharmaceutical, medical device and life science companies.

    Read more about the company

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