【Alexion Japan】Senior Manager, Regulatory Affairs CMC Japan

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: