Please note that this is a 1 year contract position.
The Manager, Regulatory Affairs will contribute to Transfusion Medicine (TM) Regulatory Strategies and content plans. The primary responsibility is to support the day-to-day Regulatory Affairs operations within the Transfusion Medicine Regulatory Affairs Business Field and will manage and oversee the coordination, compilation and submission of Regulatory Applications to Regulatory Agencies. The Responsibilities • Responsible for interpreting regulatory requirements and determining strategy to obtain registrations. Independently make decisions regarding work processes or operational plans and schedules in order to achieve department and project objectives. • Represent Company to US Regulatory agencies and interact with EU, International Health Ministry personnel to expedite pending applications, resolve Regulatory matters and manage development meetings for Regulatory Submissions. • Provide guidance to business partners regarding Regulatory requirements including indications of risk and approximate timing for approvals for planning purposes. Supports both new product development and currently marketed product portfolio within the Transfusion Medicine Business Field. • Independently execute activities related to maintaining compliant Regulatory status for marketed products including annual reporting, change management, labeling review, etc. • Actively represent Company in External influence activities with Industry Trade associations, Standardization organizations etc. to stay abreast and impact policies and standards applicable to the Company business.
For consideration, please reference job number 2921