Alexion Pharmaceuticals

【Alexion Japan】Senior Manager, Regulatory Affairs CMC Japan

📍 Location

Japan, Tokyo

⏰ Job Type

Full time

📅 Posted

June 18, 2026

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...
        

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