Manager, Regulatory Affairs – Global Labeling

🔥 9 minutes ago

🇺🇸 United States – Remote

💵 $106.4k - $159.6k / year

⏰ Full Time

🟠 Senior

🔴 Lead

🚔 Compliance

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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GE HealthCare

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1892

🏥 Healthcare

💊 Pharmaceuticals

Healthcare • Medical Technology • Pharmaceuticals

GE HealthCare is a leader in precision care, dedicated to providing innovative technologies and integrated solutions that enhance healthcare services. As a stand-alone company, it focuses on imaging, ultrasound, and healthcare IT, empowering clinicians and improving patient outcomes through advanced medical technologies and personalized care solutions. With a significant investment in research and development, GE HealthCare aims to transform healthcare by making hospitals more efficient and therapies more precise.

📋 Description

• 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

• 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

• 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