Join Amneal Pharmaceuticals and be part of a agile 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

📌 Assistant Manager, Labeling Reviewer (Ahmedabad)
🏢 Amneal Pharmaceuticals
📍 Ahmedabad