Assistant Manager, Labeling Reviewer

Amneal Pharmaceuticals; Ahmedabad District; Presencial; INR 1.200.000 - 2.000.000; Tempo integral

Resumo da vaga

Amneal Pharmaceuticals LLC in Ahmedabad, India, seeks a senior Regulatory Labeling professional to define and lead labeling strategies for India, EU, Canada, and ROW markets. You will ensure CDS/CCSI alignment, harmonize content across regions, and oversee lifecycle management of artwork and labeling documents.

The role requires mastery of country-specific regulations (CDSCO, EMA QRD, Health Canada) and coordination with Global Regulatory Affairs, Pharmacovigilance, QA, packaging, and supply

Qualificações

• Experience with country-specific regulatory labeling required.
• Understanding of labeling workflows and artwork processes.
• Knowledge of labeling software/tools and data integrity practices.

Responsabilidades

• 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 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.
• Lead and develop a team of international labeling professionals.
• Collaborate with Global Regulatory Affairs, Pharmacovigilance, Quality Assurance, Packaging & Artwork teams, and Supply Chain.
• Lead implementation and optimization of labeling systems (AMS, labeling content tools) and drive digital initiatives.

Conhecimentos

Regulatory labeling

Packaging & artwork

Labeling software/tools

Attention to detail

Coordination & communication

Time management

Formação

Master's Degree

Descrição da vaga

• Strong knowledge of country specific regulatory labeling requirements
• Understanding of packaging materials and artwork processes
• Familiarity with labeling software/tools
• Strong coordination and communication skills
• Time management and ability to handle multiple projects
  

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.
  

Qualifications

Master Degree