Leads the Hikma Pharmaceutical's regulatory labeling group in preparing and filing new multi-source product labeling that meets regulatory and manufacturing standards, and ensures maintenance of lifecycle product labeling. Ensures consistency of labeling across product families and compliance with policies, procedures and applicable regulatory authorities. Works closely with Senior Management on all issues surrounding labeling filings in order to obtain approvals for new products as quickly as possible. Ensures that regulatory labeling requirements for both development and lifecycle products are completed on time and in compliance with FDA, and any other country specific regulatory requirements. Responsible for regulatory review of advertising and promotional material, and preparation and filing of OPDP submissions.