Establish Core Safety Information (CSI) in the form of a CSI document where determined necessary by client for specific products Creation of Core Safety Information (CSI) and Clinical Overview (CO) documents for identified products.Potential revision / update to existing labelling documents for identified generic productsDevelopment and maintenance of regulatory compliant, competitive, and up-to-date labeling documents for assigned key development projects and marketed products.… Show more Establish Core Safety Information (CSI) in the form of a CSI document where determined necessary by client for specific products Creation of Core Safety Information (CSI) and Clinical Overview (CO) documents for identified products.Potential revision / update to existing labelling documents for identified generic productsDevelopment and maintenance of regulatory compliant, competitive, and up-to-date labeling documents for assigned key development projects and marketed products. Involved in creation of comparison table and identify the deviations and report the respective teams.Conduct Literature Search using databases such as Medline, Embase, Cochrane Library, medical journals and other proprietary databases.Monitoring innovator/reference label changes for the products assigned.To provide strategic and operational regulatory labeling input and works in close collaboration with client Regulatory Affairs, Clinical, Nonclinical, Medical, safety to ensure that the execution of global regulatory labeling plans is aligned with the global regulatory strategy and with company labeling processes and standards.Perform review activities for Regional Prescribing Information (RPI - including PI & leaflet, & IFUs) as appropriate for submission and prior to artwork creation. Show less