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
- Robust 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

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