Manager Global Labeling/Operations (Drug Listing)

In this role, you will oversee key operational labeling activities and ensure regulatory accuracy and consistency across U.S. and global drug listing processes, supporting both compliance and cross-functional execution. You will:

• Manage U.S. Structured Product Labeling (SPL), including drug listings (bulk and finished) and establishment registrations in alignment with FDA requirements
• Perform bi-annual updates and submissions for FDA-required drug listings and establishment registrations
• Act as a subject matter expert for U.S. SPL, partnering with external service providers to ensure accurate and timely delivery
• Review, track, and coordinate updates to Country Product Information (CPI), including QC, formatting, copy editing, and version control
• Collaborate with global stakeholders to monitor labeling standards, requirements, and developments across regions
• Participate in cross-functional labeling meetings to evaluate updates, differences in source reference labels, and regulatory impact
• Maintain labeling history records and respond to labeling-related inquiries across internal functions
• Support compliance activities including audits, inspections, escalation handling, and non-conformance resolution
• Contribute to continuous improvement of labeling tools, processes, documentation, and tracking systems
• Ensure all activities comply with SOPs, regulatory standards, and internal quality requirements

Requirements

The ideal candidate brings strong pharmaceutical regulatory experience with deep knowledge of labeling operations and structured product requirements in both U.S. and global contexts. You should have:

• Bachelor’s degree or higher in Life Sciences or a related field
• At least 4 years of pharmaceutical industry experience
• Minimum 2 years of hands-on experience in product labeling and labeling regulations
• Strong understanding of FDA requirements, including SPL, NDC, DUNS, FEI, and GTIN frameworks
• Experience working in both local and global regulatory labeling environments
• Proven ability to manage multiple projects under tight deadlines across global teams
• Strong project management, problem-solving, and analytical thinking skills
• Excellent written and verbal communication abilities with strong attention to detail
• Experience using Microsoft Office, document management systems, and labeling tracking tools
• Collaborative, adaptable mindset with strong integrity and ability to work in cross-functional teams
• Ability to work independently in a remote environment while managing competing priorities

Benefits

• Competitive annual base salary: $100,000 – $131,300 (based on experience and qualifications)
• Eligibility for annual incentive bonus program
• Comprehensive medical, dental, and vision insurance coverage
• Access to company retirement and savings plans
• Paid time off and holiday benefits
• Employee assistance and wellness programs
• Remote work flexibility with occasional travel requirements
• Professional development opportunities in global regulatory and labeling operations
• Inclusive and diverse workplace culture committed to equity and collaboration