Regulatory Labeling Project Specialist

GSK; Durham (NC); On-site; USD 90,000 - 130,000; Full time

Job summary

GSK is seeking a regulatory labeling professional to ensure prescribing information for US products meets all regulatory requirements. The role involves developing FDA-compliant XML labeling and coordinating with cross-functional teams to resolve labeling issues, ensuring accurate version control and timely submissions.

The ideal candidate has a science or life science degree, familiarity with FDA labeling regulations, and strong communication skills to collaborate with Matrix teams and labeling

Qualifications

• Understanding of regulatory labeling requirements for US submissions and internal policies.
• Proficient with common computer software applications.
• Familiarity with medical terminology.

Responsibilities

• Ensure US prescribing information meets regulatory requirements.
• Develop FDA-compliant XML labeling documents for submissions.
• Coordinate with Labeling Strategy and Matrix Team to resolve issues.
• Maintain version control of labeling submissions and components.
• Provide regulatory advice regarding prescribing information requirements to development projects.

Skills

Regulatory labeling

XML labeling

Communication

Matrix leadership

Project coordination

Education

Science or Life Science degree

Job description

GSK is seeking a regulatory labeling professional to ensure prescribing information for US products meets all regulatory requirements. The role involves developing FDA-compliant XML labeling and coordinating with cross-functional teams to resolve labeling issues, ensuring accurate version control and timely submissions.

The ideal candidate has a science or life science degree, familiarity with FDA labeling regulations, and strong communication skills to collaborate with Matrix teams and labeling