Senior Labeling Project Coordinator

Jobtailor; Santa Monica (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

Jobtailor is seeking a labeling subject matter expert in Santa Monica to guide Regulatory Affairs, Legal, Package Engineering, and Quality Assurance on design, approvals, and implementation of product labeling.

You will lead cross-functional labeling projects, coordinate site implementations, and drive process improvements while ensuring FDA and cGMP compliance; strong writing and communication skills are essential.

Qualifications

• At least 5 years of relevant experience with a BS/BA, or at least 4 years of relevant experience with an MS.
• 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 relationships.
• Proficiency with Microsoft Office applications.
• Ability to develop process improvements, drive operational changes, and work effectively in ambiguous or evolving environments.
• Labeling experience preferred.

Responsibilities

• Serve as a labeling subject matter expert 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

Skills

Labeling Operations

Cross-Functional Project Management

FDA Regulations

cGMP Compliance

Technical Writing

Verbal Communication

Education

BS/BA degree

MS degree

Tools

Microsoft Office

Job description

• 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