Required Skills

JOB DESCRIPTION

Preferred Skills

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.

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

Maintain labeling documentation, templates, and checklists.
Ensure compliance with data integrity and documentation practices.
Support implementation and continuous improvement of labeling systems and processes.

Contribute to standardization and harmonization of labeling processes across regions.
Support global initiatives for Artwork Management Systems (AMS) and labeling tools.
Track KPIs such as cycle time, right-first-time approvals, and compliance metrics.

Drive digital initiatives (e.g., labeling intelligence, automation programs like ALI).
Ensure data integrity, compliance, and system efficiency.

Qualifications

Master Degree

Assistant Manager, Labeling Reviewer