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
* Strong 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

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