Senior Manager, Global Labeling Strategy
Core
Drives global labeling strategy and manages the review/approval process for regulatory documents (CCDS, USPI, SmPC) to support low-to-medium complexity lifecycle management projects.
Role type
Senior Manager, Regulatory Labeling Strategy
Builds
Regulatory labeling documents (Company Core Data Sheets, US Package Inserts, EU Summary of Product Characteristics)
Domain
Life Sciences / Pharmaceutical Regulatory Affairs
Required skills
Regulatory labeling expertise, Lifecycle Management (LCM) project management, Cross-functional coordination, Compliance review, Strategic planning, Health Authority inquiry response
Preferred skills
CCDS experience, GxP knowledge, Drug development and commercialization understanding, Major region labeling experience
Technologies
None stated
Responsibilities
Drive labeling strategy with Global Regulatory Leader, Serve as primary contact for Labeling Strategy Team, Coordinate multifunctional label review and approval process, Ensure effective planning of cross-functional activities, Review country labels for compliance, Support responses to Health Authority inquiries, Participate in process improvement initiatives
Seniority
Senior Manager, hands-on leadership