Build Our Future Together
At Regeneron, we believe that the right idea, combined with the right team, can transform lives. Our global teams are dedicated to discovering, developing, and delivering life-changing medicines for people with responsible diseases. We are committed to scientific excellence, innovation, and improving patient outcomes worldwide.

We are seeking a Regulatory Affairs Labeling Specialist to join our Regulatory Affairs team in Hyderabad. In this role, you will support global regulatory labeling activities, ensuring compliance, accuracy, and operational excellence across labeling documents, submissions, workflows, and reporting processes. You will collaborate closely with Regulatory Labeling Leads, operations teams, and cross-functional stakeholders to maintain high-quality product labeling and support global regulatory compliance.

When & Where
Location: Hyderabad, India (Hybrid)

Discover Your Role
- Support Regulatory Labeling Leads in managing labeling compliance activities and tracking deviations from Company Core Data Sheets (CCDS).




- Maintain safety variation trackers, labeling compliance trackers, and other regulatory documentation.
- Contribute labeling inputs for annual reports and periodic safety reports (PBRER/PADER) for assigned products.
- Conduct competitor labeling analysis using digital tools, including AI-enabled applications.
- Perform quality control reviews for EU linguistic reviews and localization activities for SmPCs and Package Leaflets.
- Format, hyperlink, proofread, and quality check CCDS, USPI, and SmPC documents according to regulatory standards and checklists.
- Perform text comparison, annotation reviews, and cumulative redline preparation for labeling updates.
- Create and coordinate Structured Product Labeling (SPL) development, validation, and regulatory submissions.
- Support packaging update activities and associated Veeva workflows.
- Manage labeling workflows within Veeva and support system updates, testing, and

📌 Regulatory Affairs Labeling Specialist (Hyderabad)
🏢 Regeneron Pharmaceuticals
📍 Hyderabad