Position: Manager, Regulatory Affairs Strategic Global Labeling
The Manager, Regulatory Affairs Strategic Global Labeling, has overall accountability for the initial creation and relevant updates to labeling documents for their assigned development and marketed products. This includes global labeling (e.g. CCDS/CCSI) and US/EU labeling (e.g. package inserts) documents.

The Manager also represents the organization at Senior level meetings (e.g., Executive Labeling Committee [ELC] meetings) regarding these labeling documents.

Responsibilities:

• Interacts with business partners and global affiliates in providing strategic guidance as appropriate to ensure consistency and compliance of product labeling.
• Drives strategic labeling processes within teams based on knowledge of success with other products. Makes recommendations to proactively optimize label language for assigned products.
• Maintains accurate files of labeling change history and associated documents, including annotations to data sources.