Senior Labeling Project Coordinator

Serve as a labeling subject matter expert and provide guidance across Regulatory Affairs, Legal, Package Engineering, and Quality Assurance Review and approve label design templates Lead and support complex labeling projects requiring independent judgment and innovative problem-solving Manage cross-functional labeling implementation activities to execute product labeling changes accurately and within required timelines Coordinate new labeling implementation with Materials Management and multiple manufacturing or packaging sites Drive completion of complex labeling processes while ensuring regulatory and business compliance Develop and recommend process improvements for labeling operations and workflows Author, revise, and improve systems, procedures, and SOPs Ensure labeling activities comply with FDA regulations, cGMP requirements, and applicable regulatory guidance documents Facilitate cross-functional communication and alignment to resolve labeling issues Support continuous improvement initiatives focused on labeling accuracy, compliance, consistency, and operational excellence Requirements At least 5 years of relevant experience with a BS/BA degree, OR at least 4 years of relevant experience with an MS degree Pharmaceutical industry experience required Strong knowledge of FDA regulations, cGMP requirements, and regulatory guidance documents Demonstrated expertise in product labeling operations and labeling implementation processes Strong verbal communication, technical writing, and interpersonal skills Experience managing complex cross-functional projects and stakeholder relationshipsProficiency with Microsoft Office applications Ability to develop process improvements, drive operational changes, and work effectively in ambiguous or evolving environments Labeling experience preferred Core Competencies Demonstrates expertise in product labeling operations, ensuring compliance with FDA regulations and cGMP requirements while driving process improvements and managing complex cross-functional projects effectively. Highest-signal resume keywords FDA Regulations CGMP Requirements Product Labeling Operations Cross-Functional Project Management Technical Writing Hard Skills Labeling Implementation Processes Process Improvements Regulatory Guidance Documents Label Design Templates SOP Development Soft Skills Verbal Communication Interpersonal Skills Problem-Solving Industry Keywords Pharmaceutical Industry Labeling Compliance Operational Excellence Tools & Technologies Microsoft Office #J-18808-Ljbffr Jobtailor