Description

The Regulatory Affairs Manager II in International Regulatory Affairs is a regulatory specialist with project management capabilities responsible for leading the end-to-end planning, coordination, and execution of assigned deliverables, including delivery as an individual contributor. The Regulatory Affairs Manager II in International Regulatory Affairs will be responsible for tactical delivery of Int’l Marketing Authorisation Applications (MAAs) and Clinical Line Extensions (CLEs within an assigned Global Regulatory Execution Team (GRET). The Regulatory Affairs Manager II is expected to be able to work flexibly to deliver these accountabilities as assigned to them by their line manager or by the Lead Regulatory Project Manager (RPM) for their allocated GRET(s).

The Regulatory Affairs Manager II is fully proficient in applying established standards. Performs Regulatory Affairs Management for highly complex International market submissions unde...