Regulatory Affairs Labeling Specialist

Overview

Regulatory Affairs Labeling Specialist supporting global regulatory labeling activities for assigned products in Hyderabad.

What you'll do

• Support Regulatory Labeling Leads with labeling compliance activities and deviation tracking from CCDS.
• Maintain safety variation trackers, labeling compliance trackers, and other regulatory documentation.
• Contribute labeling inputs for PBRER/PADER annual and periodic safety reports.
• 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 and quality check CCDS, USPI, and SmPC documents per regulatory standards and checklists.
• Manage labeling workflows in Veeva and support system updates, testing, and process improvements.

What you'll need

• Bachelor’s degree in Life Sciences, Pharmacy, Health Sciences, or related scientific field.
• 2+ years of experience in biotechnology or pharmaceutical industry, preferably regulatory labeling/affairs.
• Knowledge of global regulatory requirements and health authorities including FDA and EMA.
• Strong expertise in Microsoft Word and proficiency with Microsoft Office applications.
• Regulatory document management experience with Veeva Vault preferred.
• Familiarity with Structured Product Labeling (SPL), labeling quality control, and submission processes.
• Excellent attention to detail and ability to manage multiple priorities simultaneously.

Details

• Location: Hyderabad, India (Hybrid).