Manager, Regulatory Affairs – Global Labeling, PDx

GE HealthCare

4d•$106,400 - $159,600

About The Position

The Manager, Regulatory Affairs – Global Labeling is responsible for developing and executing global labeling strategies for assigned PDx products, with primary accountability for US FDA labeling activities and US Prescribing Information. The role partners with Clinical, CMC, Safety, Medical, Commercial, global Regulatory Affairs, and regional Regulatory Affairs teams to ensure labeling is scientifically sound, globally aligned, and supports product development, registration, lifecycle management, and commercialization. The position leads global labeling strategy, particularly for US FDA requirements, and provides labeling input to development programs, lifecycle management, and regulatory submissions. It leads preparation and review of US labeling content, supports FDA interactions and labeling negotiations, and assesses regulatory risks and the impact of FDA feedback on development and commercialization plans. The role also supports labeling governance and compliance, CCDS creation and maintenance, regional implementation, documentation, and tracking of labeling changes across US and global markets. It contributes to labeling metrics, systems, best practices, and continuous process improvement.

Requirements

7+ years of Regulatory Affairs experience, including significant experience in labeling.
Strong knowledge of FDA labeling requirements and 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.

Nice To Haves

Experience interacting with FDA on labeling matters.
Knowledge of EU and global labeling requirements.
Experience with Veeva RIM or similar regulatory systems.
Degree in Life Sciences, Pharmacy, or a related field.

Responsibilities

Lead global labeling strategy for assigned products, 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 to develop clear and defensible labeling positions.
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 across the organization.
Support CCDS creation, maintenance, version control, and change-control activities.
Assess US labeling decisions for global impact and ensure they are reflected in global labeling governance.
Coordinate with global regulatory leads and regional RA teams to evaluate local implementation requirements, document deviations or exceptions from CCDS, and maintain rationale for regional differences.
Track implementation of 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 to support global visibility and inspection readiness.

Benefits

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
May be eligible for performance-based incentive compensation, including cash bonuses and/or long-term incentives