Join Amneal Pharmaceuticals and be part of a dynamic Global Regulatory Affairs team focused on delivering compliant, high-quality labeling solutions across international markets.

Location: Ahmedabad

Qualification: B.Pharm / M.Pharm / Life Sciences

Experience: Relevant experience in International Regulatory Labeling

Key Responsibilities

Regulatory Labeling Strategy & Compliance

Define and execute labeling strategies for India, EU, Canada, and ROW markets.
Ensure alignment of local labeling with Core Data Sheet (CDS) and Company Core Safety Information (CCSI).
Drive harmonization of labeling content across regions while addressing country-specific regulatory requirements.
Review labeling content in line with regulatory requirements for India, EU, Canada, and ROW markets including Asia, Africa, MENA, CIS, and LATAM.
Ensure labeling content remains consistent with approved dossiers, SmPCs, Product Information, and local regulatory approvals.
Maintain consistency in labeling formats, terminology, and design templates across markets.

Artwork Management

Review and verify artwork for technical accuracy, regulatory compliance, and readability.
Manage artwork lifecycle activities from initiation through approval and implementation.
Ensure effective version control and archival of approved artworks.
Collaborate with packaging and artwork teams to support timely launches and lifecycle changes.
Regulatory Review & Documentation
Perform detailed reviews of labeling components against approved submissions, country-specific regulations, and internal procedures.
Identify gaps and ensure timely implementation of regulatory updates, variations, and safety changes.
Support responses to regulatory agency queries related to labeling activities.
Maintain labeling documentation, templates, checklists, and compliance records.
Ensure adherence to data integrity and documentation practices.

Process Improvement & Digital Initiatives

Support standardization and harmonization of labeling processes across markets.
Contribute to implementation and continuous improvement of Artwork Management Systems (AMS) and labeling tools.
Support digital initiatives, automation programs, and labeling intelligence projects.
Track and improve KPIs such as cycle time, compliance metrics, and right-first-time approvals.
Cross-Functional Collaboration
Work closely with Global Regulatory Affairs, Pharmacovigilance, Quality Assurance, Packaging Development, Artwork Teams, and Supply Chain.
Support global product launches, renewals, variations, and post-approval changes.
Facilitate effective communication across internal and external stakeholders to ensure timely project delivery.

Preferred Skills & Experience

Strong knowledge of country-specific labeling regulations and requirements.
Understanding of packaging materials, artwork development, and change control processes.
Experience in international labeling for India, EU, Canada, and ROW markets.
Familiarity with labeling software, artwork management systems, and digital labeling tools.
Knowledge of pharmacovigilance-driven labeling updates and safety-related changes.
Excellent attention to detail, communication, coordination, and project management skills.
Ability to manage multiple priorities while maintaining quality and compliance standards.
Exposure to automation and digital transformation initiatives within labeling operations will be an added advantage.

If you are passionate about global labeling compliance and regulatory excellence, we would love to connect with you. Please share CV at [HIDDEN TEXT] with a cc to [HIDDEN TEXT]

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Assistant Manager, Labeling Reviewer