Manager, Regulatory Affairs – Global Labeling

GE HealthCare

. Develop and execute global labeling strategies for assigned PDx products .

Posted 10/16/2026full-timeRemote • United StatesSeniorLead💰 $106,400 - $159,600 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive expertise in Regulatory Affairs with a strong focus on FDA labeling requirements and the ability to manage complex projects across cross-functional teams. Proficient in developing and maintaining US labeling and CCDS while ensuring compliance with global regulatory standards.

Highest-signal resume keywords

Regulatory Affairs ExperienceFDA Labeling RequirementsUS Regulatory SubmissionsLabeling Development and MaintenanceVeeva RIM Experience

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Labeling Strategy DevelopmentRegulatory Risk AssessmentLabeling Content PreparationLabeling Governance ProcessesLabeling Metrics Contribution

Soft Skills

Cross-Functional Team InfluenceExcellent Communication SkillsProject Management

Tools & Technologies

Veeva RIMRegulatory Systems

Industry Keywords

Life SciencesPharmacyFDA InteractionsCCDS MaintenanceInspection-Ready Documentation

About the role

Key responsibilities & impact

Develop and execute global labeling strategies for assigned PDx products
Lead global labeling strategy with primary focus on US FDA requirements and labeling expectations
Provide labeling input to development programs, lifecycle management activities, and regulatory submissions
Ensure alignment between US labeling, CCDS, and regional implementation strategies
Lead preparation and review of US labeling content, including USPI and FDA labeling updates
Support FDA interactions and labeling negotiations
Assess regulatory risks and communicate the impact of FDA feedback on development and commercialization plans
Partner with Clinical, CMC, Safety, Medical, Market Access, Commercial, Legal, and Ad Promo teams
Translate complex regulatory requirements into business-relevant recommendations
Support labeling governance processes and ensure inspection-ready documentation
Drive timely implementation of labeling changes and continuous process improvement
Contribute to labeling metrics, systems, and best practices
Support CCDS creation, maintenance, version control, and change-control activities
Coordinate with global regulatory leads and regional Regulatory Affairs teams on local implementation requirements
Document regional deviations or exceptions from CCDS and maintain rationale
Track labeling changes across US and global markets, including milestones, dependencies, approvals, exceptions, and closure status
Maintain labeling trackers, action logs, decision records, and implementation status

Requirements

What you’ll need

7+ years of Regulatory Affairs experience, including significant experience in labeling
Strong knowledge of FDA labeling requirements
Experience supporting 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
Experience interacting with FDA on labeling matters (preferred)
Knowledge of EU and global labeling requirements (preferred)
Experience with Veeva RIM or similar regulatory systems (preferred)
Degree in Life Sciences, Pharmacy, or related field (preferred)
Must be legally authorized to work in the United States
GE HealthCare will not sponsor employment visas
Successful completion of a drug screen, as applicable
Some customers may have vaccination mandates applicable to certain employees

Benefits

Comp & perks

Medical insurance
Dental insurance
Vision insurance
Paid time off
401(k) plan with employee and company contribution opportunities
Life insurance
Disability insurance
Accident insurance
Tuition reimbursement
Professional development
Competitive compensation
Performance based incentive compensation, which may include cash bonus(es) and/or long term incentives (LTI)
Relocation assistance not provided