Hub Labeling Manager

Job description

Purpose The HUB Labeling Manager will be 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: Maintains system management for labeling activities including Global Document Management System (GDMS) and Pfizer approved labeling tracking system. Maintenance of workflow management tools and mailboxes. Monitors system data integrity and quality checks. Utilizes regulatory knowledge to produce non-complex LPDs, LLDs and PLDs. Produces other labeling-related documentation for submission to HAs such as track change versions, annotated la...