Executive, Labeling Compilation
Amneal Pharmaceuticals
- Labeling compilation for Europe, Canada, Asia, Africa, MENA, CIS, and Latam etc.
- Drafting and formatting product labels, packaging inserts, cartons, and leaflets according to regulatory and corporate guidelines.
- Ensure consistency in label format, design, and terminology in line with product-specific requirements and standard templates.
- Support the review of labeling content to ensure compliance with applicable Country specific regulatory requirements for markets like Asia, Africa, MENA, CIS, Latam etc.
- Cross-check information on labels such as drug name, strength, dosage form, batch number, manufacturing/expiry dates, and barcode requirements etc. as per checklist.
- Collaborate with Regulatory Affairs, Quality Assurance, Medical Affairs, IT and Packaging departments for input and approvals.
- Coordinate with artwork or design teams to ensure label layout and design are accurate and approved.
- Maintain accurate records of label versions, approval status and change history.
- Assist in implementing updates to existing product labels due to regulatory changes, safety updates, or product modifications.
- Track and manage timelines to ensure timely rollout of updated labels across all batches and packaging lines.
- Ensure labeling materials meet internal quality standards and are free of errors.
- Undergo training on relevant Standard Operating Procedures (SOPs), regulatory guidelines, and systems used for labeling.
- Adhere strictly to SOPs, company policies, and Good Manufacturing Practices (GMP) during all labeling activities.
- Report discrepancies, labeling errors, or deviations immediately to supervisors and assist in corrective actions.
- Participate in root cause analysis for labeling-related issues and contribute to preventive measures.
- Help prepare and compile labeling components for inclusion in regulatory submissions.
- Provide administrative support for compiling labeling-related annexes, summaries, and justifications.
- Stay updated with changes in international labeling regulations and guidance documents.
- Take initiative in learning new tools, labeling software, or process improvements suggested by team leads or supervisors.
B. Sc., M. Sc., B. Pharm,