Manager, Finished Goods Labeling

You will be responsible for the commercial product labeling creation and maintenance for our growing portfolio of products and global markets. This includes significant cross functional efforts with colleagues in CMC, Supply Chain Operations, Quality Assurance, and CMC-Regulatory Affairs, while serving as an important point of contact for labeling process issues. This role would also be the business owner of a labeling and artwork management system and occupy a visible role in the training of others and the maintenance of the given GLAMS system.

• →Coordinate the creation, revision, review, and approval of product labeling including carton/container labels and artwork components.
• →Manage labeling workflows and document control activities within Perigord GLAMS label management system with Veeva RIM impacts.
• →Maintain labeling version control, archival records, and audit-ready documentation.
• →Support regulatory submissions involving labeling changes for U.S., EU, and additional global markets.
• →Track labeling change requests and ensure timely implementation across stakeholders.
• →Collaborate with Regulatory Affairs to ensure labeling aligns with FDA, EMA, and other global regulatory authority requirements.
• →Coordinate cross-functional reviews with Medical, Safety, Clinical, Quality, Legal, and Commercial teams.

• Bachelor’s degree in a scientific, regulatory, or related field.
• Direct hands-on experience using Perigord GLAMS label management system (required).
• Experience coordinating labeling activities for pharmaceutical or biotechnology products.
• Working knowledge of U.S. FDA labeling regulations and familiarity with EU and international labeling requirements.
• Experience supporting labeling updates across multiple products or programs.
• Strong organizational skills and ability to manage multiple labeling projects simultaneously.