Manager, Regulatory Affairs – Global Labeling, PDx

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

Job Description Summary

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.

Job Description

Key Responsibilities

Global Labeling Strategy

• 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.

FDA Labeling Leadership

• 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.

Cross-Functional Collaboration

• 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.

Governance & Compliance

• 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.

**CCDS Alignment & Global Implementation**

• Support CCDS creation, maintenance, version control, and change-control activities, ensuring US labeling decisions are assessed for global impact and properly 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 transparent 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.

Required Qualifications

• 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.

Preferred Qualifications

• 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 related field.

We will not sponsor individuals for employment visas, now or in the future, for this job opening.For U.S. based positions only, the pay range for this position is $106,400.00-$159,600.00 Annual. It is not typical for an individual to be hired at or near the top of the pay range and compensation decisions are dependent on the facts and circumstances of each case. The specific compensation offered to a candidate may be influenced by a variety of factors including skills, qualifications, experience and location. In addition, this position may also be eligible to earn performance based incentive compensation, which may include cash bonus(es) and/or long term incentives (LTI). GE HealthCare offers a competitive benefits package, including not but limited to medical, dental, vision, paid time off, a 401(k) plan with employee and company contribution opportunities, life, disability, and accident insurance, and tuition reimbursement.

Additional Information

GE HealthCare offers a great work environment, professional development, challenging careers, and competitive compensation. GE HealthCare is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.

GE HealthCare will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable).

While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID-19, some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees.

Relocation Assistance Provided: No