Regulatory Labeling Expert

Key Responsibilities:

• Prepare, revise, and maintain Company Core Data Sheets (CCDS) as well as US and EU product labelling for assigned products throughout their lifecycle.
• Oversee the end-to-end (E2E) labelling process, including:
• Coordination and management of labelling reviews and approvals.
• Compilation and submission of labelling documentation to regulatory authorities.
• Active participation in regulatory labelling negotiations leading to approvals or labelling updates.
• Timely release and implementation of labelling across global functions.
• Provide leadership and strategic direction to cross-functional labelling teams, particularly for complex or high-impact labelling initiatives.