Head of Core Labeling Strategy
6 days ago
Purpose of the Associate Director/Director Role
The purpose of the Associate Director/Director, Global Regulatory Affairs (GRA) Global Core Labeling (P4/P4-2) role is to lead the development and maintenance of global labeling, including all core labeling documents related to drug, device, CMC, and carton/container components.
This role ensures timely delivery of global labeling to Lilly affiliates to facilitate simultaneous global submissions. Additionally, the Associate Director/Director leads timely updates and communication of core labeling changes throughout the product lifecycle.
Key Responsibilities:
- Provide leadership for development of global labeling strategy to facilitate global simultaneous submissions.
- Implement 'Accelerate Reach and Scale' initiatives related to global labeling strategy.
- Serve as global labeling representative for assigned products to drug development teams and affiliate regulatory business partners.
- Lead the development and maintenance of core labeling (i.e., Core Data Sheet (CDS), Core Device Labeling (CDL), Core Carton, Core Quick Reference Information, and Core Instructions for Use, and CMC Core Labeling Content).
- Communicate initial and revised core labeling to global affiliates and provide support and consultation, as necessary.
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