Labeling Hub Manager
Core
Ensure compliant and timely implementation of labeling updates across assigned countries and serve as a trusted subject matter expert for regional and global stakeholders on labeling initiatives.
Role type
Senior regulatory operations manager (pharmaceutical labeling)
Builds
Local labeling texts, regulatory submissions, and compliance documentation for global markets
Domain
Healthcare / Pharmaceuticals / Regulatory Affairs
Required skills
Regulatory experience with Regional Health Authorities, in-depth regional labeling knowledge, GLC requirements understanding, EU/US regulatory requirements knowledge, Regulatory Information Management System proficiency, Trackwise Change control environment management, translation vendor liaison, SOP compliance, audit support
Preferred skills
Artwork preparation knowledge, Launch Management interface, Supply Chain and Quality team collaboration, innovative approaches to product labeling
Technologies
Regulatory Information Management System, Trackwise
Responsibilities
Communicate issues and resolutions to peers and subordinates, ensure local labeling text is prepared right first time and on-time, support regional team members with health authority questions, advise on deficiencies or issues, arrange and update local labeling texts, manage labeling variations through systems, liaise with translation vendors, ensure maintenance of relevant systems according to SOPs, provide support during Medical and Regulatory Audits
Seniority
Senior, hands-on IC