Regulatory Labeling Project Coordinator - Senior

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.