Assistant Manager, Labeling Reviewer

Amneal Pharmaceuticals · Ahmedabad

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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.

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