Required Skills:
• Strong knowledge of country specific regulatory labeling requirements
• Understanding of packaging materials and artwork processes
• Familiarity with labeling software/tools
• Attention to detail
• Robust coordination and communication skills
• Time management and ability to handle multiple projects

Preferred Skills:
• Experience in International Labeling (India, EU, Canada, and ROW markets)
• Exposure to digital labeling systems / automation tools
• Knowledge of pharmacovigilance-related labeling updates

Key Responsibilities:
• Define and execute labeling strategies for India, EU, Canada, and ROW markets.

• Ensure alignment of local labeling with Core Data Sheet (CDS) / Company Core Safety Information (CCSI).

• Drive harmonization of labeling content across regions while addressing country-specific requirements.

• Review labeling content as per regulatory requirements for India, EU, Canada, and ROW (Asia, Africa, MENA, CIS, LATAM) markets.

• Ensure labeling content aligns with approved dossiers, SmPC, PI, or local regulatory approvals.





• Maintain consistency in labeling format, terminology, and design templates across markets.

• Ensure compliance with:

• CDSCO regulations and labeling requirements
• EU Guidelines (EMA, QRD templates)
• Health Canada labeling requirements
• Country-specific regulations for ROW markets (Asia, Africa, LATAM, MENA, CIS)
• Artwork Management
• Review and verify artwork for technical accuracy, regulatory compliance, and readability.
• Manage lifecycle of artwork from initiation to final approval and implementation.
• Ensure version control and archival of approved artworks.

• Regulatory Compliance & Review
• Perform detailed review of labeling components against: • Approved regulatory submissions
• Country-specific labeling regulations
• Internal SOPs and guidelines

• Identify gaps and ensure timely implementation of regulatory updates and variations.
• Support responses to regulatory queries related to labe

📌 Assistant Manager, Labeling Reviewer (India)
🏢 Amneal India
📍 India