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.