Hub Labeling Manager
Core
Prepare and update labeling documents (LPDs, LLDs, PLDs) for nationally registered pharmaceutical products across assigned markets, ensuring compliance with internal SOPs and external regulatory requirements.
Role type
Regulatory Affairs Labeling Manager
Builds
Regulatory submission packages and labeling documentation for pharmaceutical products
Domain
Life Sciences / Regulatory Affairs / Pharmaceutical Labeling
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Regulatory labeling principles, local/regional regulatory guidelines, structured data management, enterprise databases, MS Excel, MS SharePoint, MS Access, SOP adherence, quality compliance
Preferred skills
Multi-language skills, Country office registration experience, Core Data Sheet implications, Clinical Variations knowledge, project management, logical analytical writing
Technologies
SharePoint, enterprise databases, MS Excel, MS Access, MS SharePoint
Responsibilities
Review and develop labeling documents for regulatory submission, produce supporting documentation (track changes, comparison tables), perform QC checks on colleagues' work, identify process improvements, support readability testing, assist with labeling data analysis, create SharePoint web pages, respond to regulatory agency inquiries, represent company during HA inspections
Seniority
Mid-level, hands-on IC
