Senior Global Regulatory Labeling Project Lead

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

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.