HubLabelingManager(Manager)

**JOB TITLE:** Hub Labeling Manager (Manager) **REPORTS TO:** Team Lead, Hub Labeling Manager **DIVISION/BUSINESS LINE:** Pfizer Research & Development (PRD) **VERSION DATE:** 16-Aug-2023 **SUB DIVISION:** International Labeling & Artwork (ILA**)** **DEPARTMENT NAME:** Global Regulatory Sciences (GRS) **LOCATION:** Egypt, Cairo **LEVEL:** Manager(Grade: GJL070) **JOB SUMMARY** The HLM (Manager) is responsible for preparation of LPDs, associated LLDs and PLDs for nationally registered products for their assigned markets and updating the labeling documents on a timely basis according to internal SOPs and external regulatory requirements. This role may act as a Subject Matter Expert (SME) on local, regional and multi-country regulatory labeling requirements and participate in the sharing of intelligence in collaboration with other Hub Labeling Managers. Additionally, this role will serve as an SME for the use and development of current and new global tools, technologies and processes to support label development, submission and approval; with a particular focus on digital solutions. **JOB RESPONSIBILITIES** · To utilize regulatory labeling expertise to review, develop and deliver labeling documents for submission to the Regulatory Authorities across markets/regions, requesting medical advice and input from other functions as appropriate. · Performs QC check of labeling text. · Maintains system management for labeling activities including GDMS and Pfizer approved labeling tracking system. · Monitors system data integrity and quality checks. · To support provision of other deliverables within the scope of ILG responsibilities e.g. readability testing. · Identifies incremental improvements to labeling-related processes and systems for exploration by more senior labeling managers. · To work on projects involving the use of current and new global tools, technology and processes to support label development, submission and approval; with a particular focus on digital solutio