RA Senior Manager

勤務地 日本
業界・業種 医療・製薬
契約タイプ Permanent
給料 13,000,000 JPY
参照番号 36736


One of the largest generic pharmaceutical companies in the world with global revenues of over 5 billion USD. They have multiple manufacturing facilities, and are providing high-quality, affordable medicines. They are trusted by healthcare professionals and patients, in more than 100 countries around the world.



  • Applying for approval of new drugs and generic drugs, responding to reviews, and obtaining approval.

  • Formulation of regulatory affairs strategies at the development stage.

  • Coordination of the project team in PMDA consultations.

  • Contact point for new applications, compilation of approval application materials, preparation of fixe deposit application forms.

  • Leading the planning and finalization of pharmaceutical strategies for clinical trials and approval applications.

  • Appropriate notification and education of Japanese pharmaceutical regulations to overseas development departments.



  • Bachelor's degree or above (bachelor's degree related to life science such as chemistry, pharmacy, etc. is acceptable)

  • More than 10 years’ experience in at a pharmaceutical company with More than 5 years of experience in new drug development regulatory affairs.

  • Experience leading new drug or generic drug applications.

  • Business-level English skills required.