$89K - $134K/yr
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 ...
$89K - $134K/yr
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 ...
Mylan Inc. Viatris is a global healthcare company uniquely positioned to bridge the traditional ... Director Core Labeling Strategy role will make an impact: Key responsibilities for this role ...
Mylan Inc. Viatris is a global healthcare company uniquely positioned to bridge the traditional ... Director Core Labeling Strategy role will make an impact: Key responsibilities for this role ...
Billerica, MA · On-site
$159K - $210K/yr
Your Role The Director of Global Labeling (Director of GL) provides strategic regulatory labeling expertise and operational leadership to cross functional teams, ensuring the successful development ...
Billerica, MA · On-site
$159K - $210K/yr
Your Role The Director of Global Labeling (Director of GL) provides strategic regulatory labeling expertise and operational leadership to cross functional teams, ensuring the successful development ...
Billerica, MA · Hybrid
$159K - $210K/yr
The Director of Global Labeling (Director of GL) provides strategic regulatory labeling expertise and operational leadership to cross functional teams, ensuring the successful development of company ...
Billerica, MA · Hybrid
$159K - $210K/yr
The Director of Global Labeling (Director of GL) provides strategic regulatory labeling expertise and operational leadership to cross functional teams, ensuring the successful development of company ...
Billerica, MA · On-site
$159K - $210K/yr
The Director of Global Labeling (Director of GL) provides strategic regulatory labeling expertise and operational leadership to cross functional teams, ensuring the successful development of company ...
Billerica, MA · On-site
$159K - $210K/yr
The Director of Global Labeling (Director of GL) provides strategic regulatory labeling expertise and operational leadership to cross functional teams, ensuring the successful development of company ...
This strategic role expands beyond traditional medical device labeling to oversee global compliance for environmental sustainability mandates, materials of concern, and circular economy requirements.
This strategic role expands beyond traditional medical device labeling to oversee global compliance for environmental sustainability mandates, materials of concern, and circular economy requirements.
This strategic role expands beyond traditional medical device labeling to oversee global compliance for environmental sustainability mandates, materials of concern, and circular economy requirements.
This strategic role expands beyond traditional medical device labeling to oversee global compliance for environmental sustainability mandates, materials of concern, and circular economy requirements.
This strategic role expands beyond traditional medical device labeling to oversee global compliance for environmental sustainability mandates, materials of concern, and circular economy requirements.
This strategic role expands beyond traditional medical device labeling to oversee global compliance for environmental sustainability mandates, materials of concern, and circular economy requirements.
This strategic role expands beyond traditional medical device labeling to oversee global compliance for environmental sustainability mandates, materials of concern, and circular economy requirements.
This strategic role expands beyond traditional medical device labeling to oversee global compliance for environmental sustainability mandates, materials of concern, and circular economy requirements.
This strategic role expands beyond traditional medical device labeling to oversee global compliance for environmental sustainability mandates, materials of concern, and circular economy requirements.
This strategic role expands beyond traditional medical device labeling to oversee global compliance for environmental sustainability mandates, materials of concern, and circular economy requirements.
This strategic role expands beyond traditional medical device labeling to oversee global compliance for environmental sustainability mandates, materials of concern, and circular economy requirements.
This strategic role expands beyond traditional medical device labeling to oversee global compliance for environmental sustainability mandates, materials of concern, and circular economy requirements.
This strategic role expands beyond traditional medical device labeling to oversee global compliance for environmental sustainability mandates, materials of concern, and circular economy requirements.
This strategic role expands beyond traditional medical device labeling to oversee global compliance for environmental sustainability mandates, materials of concern, and circular economy requirements.
This strategic role expands beyond traditional medical device labeling to oversee global compliance for environmental sustainability mandates, materials of concern, and circular economy requirements.
This strategic role expands beyond traditional medical device labeling to oversee global compliance for environmental sustainability mandates, materials of concern, and circular economy requirements.
This strategic role expands beyond traditional medical device labeling to oversee global compliance for environmental sustainability mandates, materials of concern, and circular economy requirements.
This strategic role expands beyond traditional medical device labeling to oversee global compliance for environmental sustainability mandates, materials of concern, and circular economy requirements.
This strategic role expands beyond traditional medical device labeling to oversee global compliance for environmental sustainability mandates, materials of concern, and circular economy requirements.
This strategic role expands beyond traditional medical device labeling to oversee global compliance for environmental sustainability mandates, materials of concern, and circular economy requirements.
This strategic role expands beyond traditional medical device labeling to oversee global compliance for environmental sustainability mandates, materials of concern, and circular economy requirements.
This strategic role expands beyond traditional medical device labeling to oversee global compliance for environmental sustainability mandates, materials of concern, and circular economy requirements.
This strategic role expands beyond traditional medical device labeling to oversee global compliance for environmental sustainability mandates, materials of concern, and circular economy requirements.
This strategic role expands beyond traditional medical device labeling to oversee global compliance for environmental sustainability mandates, materials of concern, and circular economy requirements.
Drive the global labeling strategy, including demonstrating an understanding of competitors in the ... Direct experience with target labeling development or New Molecular Entity (NME) submissions is ...
Drive the global labeling strategy, including demonstrating an understanding of competitors in the ... Direct experience with target labeling development or New Molecular Entity (NME) submissions is ...
Drive the global labeling strategy, including demonstrating an understanding of competitors in the ... Direct experience with target labeling development or New Molecular Entity (NME) submissions is ...
Drive the global labeling strategy, including demonstrating an understanding of competitors in the ... Direct experience with target labeling development or New Molecular Entity (NME) submissions is ...
Drive the global labeling strategy, including demonstrating an understanding of competitors in the ... Direct experience with target labeling development or New Molecular Entity (NME) submissions is ...
Drive the global labeling strategy, including demonstrating an understanding of competitors in the ... Direct experience with target labeling development or New Molecular Entity (NME) submissions is ...
$15.82 is the 25th percentile. Wages below this are outliers.
$12.98 - $20.48
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$31.10 is the 75th percentile. Wages above this are outliers.
$27.97 - $35.47
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7% of jobs
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1% of jobs
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0% of jobs
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$12
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$95
For Associate Director Global Labeling Strategy jobs, the most frequently searched job titles are:
Remote
$89K - $134K/yr
Full-time
Medical, Dental, Vision, Life, Retirement, PTO
Re-posted 22 hours ago
8.3
Based on 138 frontline employees who took The Breakroom Quiz
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.
GE HealthCare offers a great work environment, professional development, challenging careers, and competitive compensation. GE HealthCare is anEqual 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
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