Assistant Manager, Labeling Reviewer

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