Remote Senior Regulatory Labeling Lead

Lo Que la Verdad Esconde; Abu Dhabi; Remote; AED 140,000 - 200,000; Full time

Job summary

Lo Que la Verdad Esconde is hiring a Senior Regulatory Labeling Specialist to manage pharmaceutical labeling across multiple markets. The role focuses on regulatory labeling submissions, updating product information, and ensuring compliance with current safety data and guidelines.

The ideal candidate will coordinate with Regulatory Affairs, Medical Affairs, Pharmacovigilance, Quality Assurance, Manufacturing, and Supply Chain to maintain accurate and compliant labeling throughout the product

Qualifications

• Strong knowledge of pharmaceutical labeling regulations.
• Experience with regulatory submissions and product information management.
• Ability to coordinate with Regulatory Affairs, Medical Affairs, Pharmacovigilance and QA.

Responsibilities

• Manage end-to-end regulatory labeling activities for products including new registrations and lifecycle changes.
• Prepare and maintain SmPCs, patient information leaflets, and other labeling documents.
• Coordinate labeling activities for launches, market expansions, and changes in ownership.
• Ensure labeling reflects approved information and safety requirements across markets.
• Track submissions, manage authority questions, and document approvals and changes.
• Maintain labeling records and align master documents with market-specific versions.

Skills

Regulatory labeling

Pharmaceutical labeling

Documentation management

Cross-functional collaboration

Change control

SmPC preparation

Job description

Lo Que la Verdad Esconde is hiring a Senior Regulatory Labeling Specialist to manage pharmaceutical labeling across multiple markets. The role focuses on regulatory labeling submissions, updating product information, and ensuring compliance with current safety data and guidelines.

The ideal candidate will coordinate with Regulatory Affairs, Medical Affairs, Pharmacovigilance, Quality Assurance, Manufacturing, and Supply Chain to maintain accurate and compliant labeling throughout the product