AHMEDABAD · FULLTIME
Assistant Manager, Labeling Reviewer
Amneal Pharmaceuticals
Ahmedabad · onsite · Posted 13d ago
Sourced from
Undisclosed1–6 yrsfulltimeAhmedabad
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Section · 01
About this role
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.
- Perform detailed review of labeling components against:
- 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.
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- 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
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- Lead implementation and optimization of labeling systems:
- Artwork Management Systems (AMS)
- Labeling content management tools
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- Drive digital initiatives (e.g., labeling intelligence, automation programs like ALI).
- Ensure data integrity, compliance, and system efficiency.
Master Degree
Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.
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Section · 02
Skills
LatamAutomationContent ManagementAutomation ToolspharmacovigilanceRegulatory AffairsCapability BuildingCore DataProcess ImprovementQuality AssuranceRegulatory ComplianceCommunication SkillscomplianceLabeling Systems
Section · Company
About Amneal Pharmaceuticals
Amneal Pharmaceuticals
Pharma
5.5k+
employees
2002
24 years old
Bridgewater, New Jersey
United States (USA)
About
Amneal Pharmaceuticals operates in the pharmaceutical sector, focusing on developing accessible and affordable medicines to address critical healthcare challenges.
Industries
PharmaBiotechnologyClinical Research
Employee ratings
1,455 reviews
4.2/ 5
Culture
4.0
Career growth
3.5
Work-life
4.2
Employees rate it well for
Work Culture190Senior Management93Work Life Balance87Work Environment69HR Policies65
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