Global Head, Regulatory Affairs – Labeling
Location
United States
Posted
51 days ago
Salary
$172.8K - $259.2K / year
Seniority
Lead
Postgraduate Degree10 yrs expEnglish
Job Description
• 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
Job 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
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