Simone Herter

-Acts as PS window person for New Product Developments -Develops detailed project timelines including on time delivery and budget planning - Identifies risks and contingencies and communicates progress to initiators. - Manages project team meetings - Identifies root causes & corrective actions for project deviations

-Act as single point of entry for assigned Technical Change Requests -Lead team for reviewing through implementation to completion of the change - Ensure that all aspects for the implementation of a change are adequately documented and corresponding activities are defined - Monitor milestones to ensure project is implemented according to defined dates and objectives

- Engaging affiliates in projects when new registrations or changes to existing registration are required by coordinating and providing documentation to support new registrations, renewals, variations, site transfers and other regulatory requirements - Partnering with affiliates, IRA staff, and manufacturing sites to define project timelines and data requirements - Properly documenting, tracking and storing regulatory documents and document requests