Assistant Manager, Labeling Reviewer at Amneal India

Ahmedabad, gujarat, India -

Full Time

Start Date

Immediate

Expiry Date

19 Oct, 26

Salary

0.0

Posted On

21 Jul, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Labeling, Artwork Management, Compliance Review, Team Leadership, Cross-functional Collaboration, Time Management, Communication Skills, Labeling Software, Pharmacovigilance, Regulatory Strategy, Quality Assurance, Data Integrity

Industry

Pharmaceutical Manufacturing

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.

Responsibilities

Lead and manage end-to-end labeling and artwork activities for international markets including India, EU, and Canada. Ensure all labeling content aligns with regulatory requirements, approved dossiers, and company safety information.