Global Labeling Lead - Regulatory Affairs

GE HealthCare; United States; Remote; USD 106,000 - 160,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Paid time off

401(k) plan

Job summary

GE HealthCare seeks a Manager, Regulatory Affairs – Global Labeling to develop and execute global labeling strategies for PDx products, with a primary focus on US FDA labeling and USPI. You will collaborate with Clinical, CMC, Safety, Medical, Market Access, and global/regional RA teams to ensure scientifically sound, globally aligned labeling.

The role leads US labeling content, supports FDA negotiations, and drives CCDS alignment, governance, and process improvements while influencing

Qualifications

• 7+ years of Regulatory Affairs experience with significant labeling work.
• Strong knowledge of FDA labeling requirements and US regulatory submissions.
• Experience developing and maintaining US labeling and/or CCDS.
• Ability to influence cross-functional teams and manage complex projects.
• Excellent written and verbal communication skills.

Responsibilities

• Lead global labeling strategy for assigned products, focusing on US FDA requirements.
• Provide labeling input to development programs and regulatory submissions.
• Ensure alignment between US labeling, CCDS, and regional strategies.
• Lead preparation and review of US labeling content, including USPI and FDA updates.
• Support CCDS creation, maintenance, and global implementation activities.

Skills

Regulatory Affairs

FDA Labeling

US Labeling

Cross-functional Leadership

Written & Verbal Communication

Education

Degree in Life Sciences, Pharmacy, or related field

Job description

GE HealthCare seeks a Manager, Regulatory Affairs – Global Labeling to develop and execute global labeling strategies for PDx products, with a primary focus on US FDA labeling and USPI. You will collaborate with Clinical, CMC, Safety, Medical, Market Access, and global/regional RA teams to ensure scientifically sound, globally aligned labeling.

The role leads US labeling content, supports FDA negotiations, and drives CCDS alignment, governance, and process improvements while influencing