Global Head, Regulatory Affairs – Labeling
GE HealthCare
full-time
Posted on:
Location Type: Remote
Location: United States
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Salary
💰 $172,800 - $259,200 per year
Job Level
About the role
- Lead the global labeling strategy for all PDx products
- Chair the Global Labeling Committee and Labeling Working Groups
- Own CCDS creation, maintenance, and change control
- Serve as the principal labeling negotiator with FDA, EMA, NMPA, PMDA
- Partner with Market Access, Commercial, Medical, and Legal to ensure compliant promotional scope
- Build and evolve the Global Labeling Center of Excellence
Requirements
- Minimum 10 years of experience leading Global Labeling in a highly regulated pharmaceutical companies
- Proven success in label negotiations and defense at FDA/EMA/NMPA/PMDA
- Demonstrated strategic influence across Clinical, CMC, Medical, Market Access, and Commercial
- Deep expertise in CCDS, core/product information, and global/local labeling execution
- Exceptional negotiation and stakeholder management skills
- Strong people leadership abilities
Benefits
- medical, dental, vision
- paid time off
- 401(k) plan with employee and company contribution opportunities
- life, disability, and accident insurance
- tuition reimbursement
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
CCDSlabel negotiationslabeling strategyglobal labeling execution
Soft Skills
negotiation skillsstakeholder managementstrategic influencepeople leadership