Description
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
- 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)
🏢 Amneal
📍 Ahmedabad