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 labeling.
Documentation & Systems
- Maintain labeling documentation, templates, and checklists.
- Ensure compliance with data integrity and documentation practices .
- Support implementation and continuous improvement of labeling systems and processes.
Process Improvement
- 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.
Team Leadership & Capability Building
Lead and manage a team of international labeling professionals.
Provide technical guidance on complex labeling requirements.
Drive training programs on global labeling regulations and systems.
Cross-functional Collaboration
Collaborate with:
Global Regulatory Affairs (submissions teams)
Pharmacovigilance (for safety updates)
Quality Assurance
Packaging & Artwork teams
Supply Chain
Support global product launches, renewals, and variations.
Digital Systems & Innovation
Lead implementation and optimization of labeling systems:
Drive digital initiatives (e.g., labeling intelligence, automation programs like ALI).
Ensure data integrity, compliance, and system efficiency.
