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Senior Manager, Regulatory Labeling
A company is looking for a Senior Manager, Global Regulatory Device Labeling Strategy Lead. Key Responsibilities Provide regulatory expertise and strategic guidance for the development and maintenance of labeling documents in compliance with US and EU standards Lead cross-functional teams to align labeling strategies and content for various products, including combination and standalone medical devices Manage the lifecycle of labeling components and ensure compliance with internal procedures and Health Authority requirements Required Qualifications 4-7 years of experience in the biopharmaceutical industry, with up to 3 years in a global labeling role preferred Bachelor's or Master's degree required; advanced scientific or health sciences degree preferred Detailed understanding of pharmaceutical drug and device development, specifically EU and US labeling regulations Expertise in developing and maintaining Company Core Data Sheet, USPI, and EU SmPC Proficiency in Electronic Document Management Systems and End-to-End Labeling Tracking Systems
A company is looking for a Senior Manager, Global Regulatory Device Labeling Strategy Lead.
Key Responsibilities
Provide regulatory expertise and strategic guidance for the development and maintenance of labeling documents in compliance with US and EU standards
Lead cross-functional teams to align labeling strategies and content for various products, including combination and standalone medical devices
Manage the lifecycle of labeling components and ensure compliance with internal procedures and Health Authority requirements
Required Qualifications
4-7 years of experience in the biopharmaceutical industry, with up to 3 years in a global labeling role preferred
Bachelor's or Master's degree required; advanced scientific or health sciences degree preferred
Detailed understanding of pharmaceutical drug and device development, specifically EU and US labeling regulations
Expertise in developing and maintaining Company Core Data Sheet, USPI, and EU SmPC
Proficiency in Electronic Document Management Systems and End-to-End Labeling Tracking Systems
