Senior Manager, Global Labeling Strategy
Core
Drives global labeling strategy and manages the review/approval process for regulatory documents (CCDS, USPI, SmPC) to ensure compliance and timely submissions for low to medium complex projects.
Role type
Senior Manager, Regulatory Labeling Strategy
Builds
Regulatory labeling documents (Company Core Data Sheets, Package Inserts, Summary of Product Characteristics)
Domain
Life Sciences / Pharmaceuticals / Regulatory Affairs
Required skills
Regulatory labeling expertise, Lifecycle Management (LCM) project management, Cross-functional coordination, Compliance review, Strategic planning, Stakeholder influence
Preferred skills
Experience with CCDS, Knowledge of GxP procedures, Understanding of drug development and commercialization
Technologies
None stated
Responsibilities
Drive labeling strategy in partnership with Global Regulatory Leader, Serve as primary contact for Labeling Strategy Team, Coordinate labeling activities of multifunctional contributors, Ensure effective planning of cross-functional labeling activities, Review country labels to ensure compliance, Support responses to Health Authorities inquiries
Seniority
Senior Manager, hands-on leadership