Description
Required Skills:
Robust knowledge of country specific regulatory labeling requirements
Understanding of packaging materials and artwork processes
Familiarity with labeling software/tools
Attention to detail
Solid 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 l

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