International Regulatory Affairs Officer

Role & responsibilities

• Prepare, review, and compile CTD / ACTD / country-specific dossiers for submission in ROW and semi-regulated markets.
• Collect and coordinate technical data (from F&D, QA, QC, ADL, and Packaging departments).
• Ensure timely submission of dossiers for new product registration, renewal, and variation.
• Prepare query responses to regulatory agencies and ensure prompt resolution.
• Prepare and review Product Registration Files (PRFs), Product Information Files (PIFs), COPP, FSC, stability data, COA, etc.
• Review and approve artworks, labels, and packaging components as per country guidelines.
• Maintain document control and version tracking for all submissions.
• Support export documentation and ensure that products meet the target markets regulatory standards
• Interact with regulatory agents, distributors, and health authorities for submissions and clarifications.
• Collaborate cross-functionally with R&D, QA, QC, Business Development and Production to ensure data readiness.
• Handle renewals, variations, and post-approval changes for existing registrations.
• Track registration status and maintain Regulatory Information Database (RID).
• Manage label updates, artwork revisions, and compliance activities post-approval.
• Monitor and update country-specific guidelines (WHO, GCC, ASEAN, LATAM, Africa, CIS, etc.).
• Support audit and inspection activities related to regulatory documentation.
• Keep management informed of changes in international regulatory frameworks affecting exports.