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,
Amneal (NASDAQ: AMRX) is rapidly becoming one of the most dynamic, purpose-driven pharmaceutical companies delivering more affordable access to essential medicines. Our family delivers for yours through a robust U.S. generics business, a growing branded business and deepening portfolios in injectables, biosimilars and select international markets. We’ve bolstered our world-class scientific rigor, production capabilities and commercial infrastructure. And we invest substantially in our people through leadership development and employee well-being programs – all so we can deliver even more value. We are Amneal and We make healthy possible.
Content is for informational purposes only and 3rd party content does not reflect Amneal’s opinions.
Amneal has the right to remove comments that violate another’s copyright or intellectual property, mention an Amneal product, use profanity or are defamatory, promote and solicit for third-party sites, initiatives, or products, or are factually inaccurate or misleading or spam.
Amneal recommends that you consult with your healthcare provider regarding personal health matters. To report a product complaint or adverse event related to an Amneal product, contact Drug Safety at 877-835-5472, option 3 or drugsafety@amneal.com. If you are currently experiencing a life-threatening event, please immediately contact 911.
