Manager, Regulatory affairs.

Updating and maintenance of harmonized/regional labeling including artwork for inserts and packaging components

Liaise with key interfaces on project requirements to ensure timelines are mutually understood.

Liaise with Labeling Manager to understand nature of change, urgency, important information for affiliates and/or implementation

Prepare global dispatch of core label information, including notice to affiliates

Enter data into systems pre-dispatch and update systems with post-dispatch activities (Appian, Vault, Vista)

Competitive labeling analysis as needed and/or requested

Monitor reference labels (from up to three countries) for updates and ability to connect with concerned affiliates directly using Sanofi communication/collaboration tools.

Identify discrepancies/issues in local implementation of corporate labels

Masters in Lifesciences or equivalent with more years of experience in regulatory Affairs/Labeling or equivalent

Knowledge of the principles and concepts of Labeling, knowledge of the principles and concepts of Labeling, including generics, authorized generics, private labels, device/combination products, how to read and interpret HA regulations and guidance, and underlying SOPs