Regulatory Labeling Project Coordinator - Senior

Integrated Resources Inc.; Foster City (CA); On-site; USD 90,000 - 120,000; Full time

Job summary

A leading company is seeking a Senior Regulatory Labeling Project Coordinator to manage labeling implementation across packaging sites globally. This role requires extensive experience in project coordination, technical writing, and regulatory compliance within the pharmaceutical sector. The successful candidate will drive operational excellence and collaborate to enhance labeling operations, ensuring compliance with FDA and cGMP standards.

Qualifications

• 6+ years of relevant experience with a BS or BA; or 4+ years with an MS.
• Prior experience in pharmaceutical or regulated industry preferred.

Responsibilities

• Coordinate new labeling implementation and allocate workload.
• Manage complex workflows in an electronic labeling management system.
• Develop systems/policies to improve labeling operations.

Skills

Project Coordination

Technical Writing

Interpersonal Skills

Microsoft Office

Knowledge of FDA and cGMP standards

Education

BS or BA

MS

Tools

Artwork Production Software

Graphic Design Software

Job description

Regulatory Labeling Project Coordinator - Senior

• Contract

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.