International Regulatory Affairs Officer

Lincoln Pharmaceuticals Ltd.; Bhadaj; In loco; INR 900.000 - 1.300.000; Tempo pieno

Descrizione del lavoro

Lincoln Pharmaceuticals Ltd. is seeking a Regulatory Affairs professional to compile CTD/ACTD dossiers for ROW markets. You will gather technical data from multiple departments and ensure timely submissions for registrations, renewals, and variations.

The role requires preparing responses to regulators, reviewing registration files, and coordinating with health authorities. You will manage document control, export paperwork, and post-approval changes across regions.

Mansioni

• 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 products meet 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.

Descrizione del lavoro

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.