Regulatory Labeling Project Coordinator - Senior

Job description

Description: Responsible for the coordination of new labeling implementation with Materials Management and Supply Chain Planners at multiple packaging sites worldwide. Allocates workload to ensure availability of required artwork for the full product range in compliance with new product approvals and existing product variation approval deadlines. Liaises with International and local Regulatory colleagues to obtain correct text, negotiate timelines and ensure that all requirements have been met. Contributes to the completion of operational excellence projects where prior precedents may not be set and outcomes require executing without prior experience. Manages complex workflows in an electronic labeling management system. Recommends improvements and develops systems/policies to enhance labeling operations. Authors standard operating procedures, guidelines and work instructions. Collaborates with team members to meet departmental goals and objectives. Completes labeling artwork updates as assigned. Knowledge, Experience and Skills: Highly capable at directing and coordinating project work. Strong verbal, technical writing and interpersonal skills. Proficient in Microsoft Office applications. Knowledge of FDA and cGMP standards as well as regulatory guidance documents. Prior experience in pharmaceutical or other regulated industry is preferred. Familiarity with artwork production and graphic design software a bonus. 6+ years of relevant experience and a BS or BA. 4+ years of relevant experience and a MS. All your information will be kept confidential according to EEO guidelines.