【Alexion Japan】Senior (Labeling) Manager Regulatory

Position Summary

Senior Manager, Regulatory Affairs should be responsible for creating Japanese Package Inserts (JPIs; Japanese Labeling) of new drugs and manage revisions of JPIs of post approval products and review of educational materials ( with the advice of Director or Associate Director as needed). Also review the process of promotional materials from Regulatory point of view. The duties include complying with Japan pharmaceutical affairs act, developing good relations with the regulatory authority, and performing pharmaceutical tasks required for product development and life cycle management in a timely and appropriate manner. Since labeling is a driver of all NDA documents, the role of this position should be specialist and experienced of JPI works.

Principal Responsibilities