💼 Full-Time Position

【Alexion Japan】Senior Manager, Regulatory Affairs CMC Japan

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Alexion Pharmaceuticals
📍 Japan, Tokyo, Japan
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Location
Japan, Japan
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Posted
June 26, 2026
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Type
Full-Time
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Full-Time Opportunity: This is a permanent, full-time position with a competitive package and real career growth potential.

Job Description

This is what you will do:

The Senior Manager, Regulatory Affairs-Chemistry, Manufacturing, and Controls (RA- CMC) in Japan will manage complex projects for CMC submission in Japan and responses to regulatory agency inquiries for Alexion’s commercial and investigational products. The duty includes collaborating with the global CMC/RA team, managing the team member of Japanese CMC regulatory, selecting and managing external contractors and proposing an appropriate budget plan for the successful CMC regulatory activities.

You will be responsible for:

  • Independently manage and accountable for assigned CMC programs, managing day-to-day delivery of plans and strategic activities for specific projects, including compliance of clinical and commercial products.
  • Plan, coordinate, and manage the development, preparation and submission of the CMC sections of Alexion’s registration dossiers and supplements (partial change application and minor change notif...