Global Labeling Lead Consultant

Job Summary

A company is looking for a Global Labeling Lead Consultant with remote options in the US.

Key Responsibilities:

• Provide strategic support and leadership to the labeling team, including guidance and feedback
• Guide the development and maintenance of Company Core Data Sheets (CCDS), Package Inserts (PI), and Summary of Product Characteristics (SPC)
• Ensure compliance with regulatory guidelines and collaborate with cross-functional teams to execute labeling activities

Required Qualifications:

• Bachelor's degree in a scientific or related field; advanced degree is a plus
• Minimum 7 years of experience in pharmaceutical labeling operations
• Strong knowledge of regulatory requirements related to pharmaceutical labeling, including FDA, EMA, and ICH guidelines
• Excellent project management skills with the ability to prioritize tasks and manage multiple projects
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint)