Labeling - Regulatory Affairs Associate / Sr Associate

When our values align, there's no limit to what we can achieve.

Join us as a Global Labeling Operations Senior Regulatory Affairs Associate , where you’ll work alongside a large, dedicated client team to drive impactful labeling operations across global markets.

In this role, you will oversee end-to-end labeling operations across multiple markets, for Foundational (US, EU, CH, DE, AU) and non-US / Central EU markets, ensuring compliance with global regulatory requirements and supporting cross-functional teams in delivering accurate, timely, and high-quality labeling updates.

This is a unique opportunity to work on diverse programs, including pandemic products and flu campaigns, while contributing to the governance, compliance, and strategy of global labeling.

Key Responsibilities :

• Manager internal global labeling and drug safety activities and coordinate bi-weekly updates
• Coordinate readability testing (planning, team review, and communications)
• Oversee translations for foundational markets (EU, CH, DE).
• Coordinate and upload CH labels to AIPS; submit approved labels to external platforms (HA, ePIL).
• Upload approved labels to internal systems (Documentum, Weblabel, intranet).
• Manage linguistic reviews and dispatch CCDS, foundational labels, and multi-market manuscripts to stakeholders.
• Perform data entry in Trackwise / Veeva and prepare annual labeling reports.
• Review and update submission content plans; prepare change control documentation for CCDS-driven changes.
• Prepare and manage Structured Product Labeling (SPL).
• Support advertising and promotional and marketing material reviews, educational materials, and social media compliance.
• Ensure compliance with country-specific regulatory requirements.
• Act as key partner to GRA Regions, Regulatory CMC and Supply Chain.

Qualifications :

Competencies :

Why Join Us :

If you’re passionate about global labeling operations and ready to make a difference in patient safety worldwide, we’d love to hear from you.