Regulatory Labeling Senior Manager

Job description

Job Description General Summary: The Regulatory Labeling Senior Manager, Rest of World (ROW) is responsible for development and maintenance of product labelling for ROW markets across all therapeutic areas. This includes prescribing and patient information and associated business processes. Key Duties and Responsibilities: Provides individual contribution in development, submission, negotiation and approval of ROW labelling. Ensures compliance with labelling governance requirements and associated business processes. Participates in label working groups and representing labelling at labelling governance meetings. Works with Labelling Operations to ensure alignment with Package Component Labelling Provides input into strategy for health authority interactions and advises stakeholders of regulatory labelling requirements regarding all aspects of labelling, including responses to questions, negotiations and inspections. Knowledge and Skills: In-depth conceptual and practical knowledge regarding labelling requirements globally, use of CCDS or reference label (US and EU) in the development and management of local labelling. Ability to develop, use, and apply knowledge of frameworks speci...