Senior Manager, Regulatory Affairs should be responsible for creating Japanese Package Inserts (JPIs; i.e. Japanese Labeling) of new drugs and manage revisions of JPIs of post approval products and review of educational materials
Job Summary
Senior Manager, Regulatory Affairs should be responsible for creating Japanese Package Inserts (JPIs; i.e. Japanese Labeling) of new drugs and manage revisions of JPIs of post approval products and review of educational materials.
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.
Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness.
Matching Summary
Senior Manager, Regulatory Affairs should be responsible for creating Japanese Package Inserts (JPIs; i.e. Japanese Labeling) of new drugs and manage revisions of JPIs of post approval products and review of educational materials.