Responsible for preparation of LPDs, associated LLDs and PLDs for nationally registered products
Update labeling documents on a timely basis according to internal SOPs and external regulatory requirements
Act as a Subject Matter Expert (SME) on local, regional and multi-country regulatory labeling requirements
Serve as an SME for the use and development of current and new global tools, technologies and processes to support label development
Maintains system management for labeling activities including Global Document Management System (GDMS) and Pfizer approved labeling tracking system
Monitors system data integrity and quality checks
Produces labeling documents for submission to HAs such as track change versions, annotated labels, comparison tables
Performs QC check of other colleagues’ work
Identifies incremental improvements to labeling-related processes and systems
Supports provision of other deliverables within the scope of ILG responsibilities e.g. readability testing
Works on projects involving the use of current and new global tools, technology and processes to support label development

Life sciences, pharmacy graduate or equivalent; or equivalent relevant professional experience
Fluency in English language important however multi-language skills are advantageous
Experience working with structured data, such as in enterprise databases, MS Excel, MS SharePoint and/or MS Access
Knowledge of key regulatory and labeling principles and local regulations
‘Hands on’ registration experience associated with development, maintenance and commercialization activities within Regulatory Affairs
Demonstrated ability to develop strong and positive working relationships across multiple cultures and locations
Demonstration of attention to detail and problem-solving skills
Proven technical aptitude and ability to quickly learn new software
Proven strength in logical, analytical and writing ability essential

Hub Labeling Manager

About this role