My client is a world renown global big pharma who are currently expanding the labeling team.
This role is focused on Labeling strategy with products mainly in the development phase.
My client is seeking a motivated team player who is ready to facilitate the generation of new and revised product labeling with key local and global disciplines.
This role can be hired on a long term remote basis for candidates in Eastern time zone.
• Responsible for the development, maintenance, and implementation of Company Core Data Sheets (CCDS) in line with international standards and guidelines.
• Provide strategic and tactical labeling expertise to teams while ensuring compliance with applicable regulatory requirements.
• Serve as the regulatory expert for labeling on the global Regulatory Affairs team to ensure that regulatory labeling requirements are met for assigned products.
• Leads cross functional teams to develop and update CCDS and other key global labeling documents
• Evaluates risks associated with CCDS content and implementation strategies, develops mitigation plans, and appropriately escalates issues to Global Labeling management and the Global Regulatory Lead
• Recommends strategies and labeling language for inclusion in key product labels, consistent with the overall product strategy and information in the CCDS, when available.
• Provides information to Global Labeling Compliance, as required, to support internal and external requirements and support audits/inspections as a labeling subject matter expert
• Liaises with US Labeling Operations and EU Labeling Operations to ensure labeling objectives and timelines are met
• Remains current with global standards, initiatives by regulatory authorities related to the CCDS and labeling, and assures that processes conform to regulatory requirements. Propose actions as needed.
• 8+ years of pharmaceutical industry experience. This is inclusive of 6 years of labeling experience or combination of 5+ years regulatory and/or related experience.
• Understanding of scientific principles and regulatory/quality systems relevant to drug development.
• Knowledge of global standards and regulations related to CCDS and Product Labeling
• US PI and EU SmPC experience required