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Amneal Pharmaceuticals

Assistant Manager, Labeling Reviewer

Amneal Pharmaceuticals
Ahmedabad, India
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  • Posted 20 hours ago
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Job Description

Required Skills

 JOB DESCRIPTION

  • 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.
Qualifications

Master Degree

More Info

Job Type:
Permanent Job
Industry:
Other
Function:
Regulatory Affairs
Employment Type:
Full time

Job ID: 149019383

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Last Updated: 11-06-2026 00:58:33 PM
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