💼 About This Role

You'll ensure the accuracy and compliance of global drug labeling activities within a highly regulated pharmaceutical environment. You'll manage structured product labeling (SPL) and drug listings while collaborating with cross-functional teams. This role directly impacts patient safety and regulatory integrity.

🎯 What You'll Do

• Manage U.S. Structured Product Labeling (SPL) and drug listings
• Perform bi-annual FDA submissions for drug listings and establishment registrations
• Review and coordinate updates to Country Product Information (CPI)
• Maintain labeling history records and support audits and inspections

📋 Requirements

• Bachelor's degree in Life Sciences or related field
• At least 4 years of pharmaceutical industry experience
• Minimum 2 years of hands-on experience in product labeling
• Strong understanding of FDA requirements including SPL, NDC, and GTIN

✨ Nice to Have

• Experience in both local and global regulatory labeling environments
• Proven project management and analytical thinking skills
• Familiarity with labeling tracking tools and document management systems

🎁 Benefits & Perks

• 💰 Competitive annual base salary of $100,000 – $131,300
• 🎯 Annual incentive bonus program eligibility
• 🏥 Comprehensive medical, dental, and vision insurance
• 🏖️ Paid time off and holiday benefits
• 🏡 Remote work flexibility with occasional travel

📨 Hiring Process

Estimated timeline: 2-4 weeks · AI estimate

1. 1Recruiter screen· 30 min
2. 2Hiring manager interview· 45 min
3. 3Technical/panel interview· 60 min