Job 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
• 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 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:

  • Artwork Management Systems (AMS)

  • Labeling content management tools

• Drive digital initiatives (e.g., labeling intelligence, automation programs like ALI).

• Ensure data integrity, compliance, and system efficiency.

Master Degree