Manager, Global Labeling Product Leader
Core
Strategic development and lifecycle management of product labeling (CCDS, USPI, EUPI) across therapeutic areas and regions to ensure compliance and support patients.
Role type
Manager, Global Labeling Product Leader
Builds
Primary and derived labeling documents for pharmaceutical products
Domain
Healthcare / Pharmaceutical Regulatory Affairs
Required skills
Regulatory Affairs, Product Labeling, Pharmaceutical Drug Development, Project Team Leadership, Document Management Systems, Scientific Communication, Global Regulatory Guidelines
Preferred skills
Advanced Degree (MS/PhD/MD/PharmD), 3+ years Regulatory Affairs Labeling Experience, Matrix Environment Leadership, Continuous Improvement, Multi-Project Management
Technologies
Document Management Systems
Responsibilities
Lead development and maintenance of primary labeling documents (CCDS, USPI, EUPI); Provide guidance on labeling content, processes, and scientific integrity; Contribute to global labeling strategy and competitor analysis; Drive continuous improvement of the end-to-end labeling process.
Seniority
Manager, hands-on IC