Job Description: Regulatory Affairs – Dossier Preparation & Lifecycle Management Requirement- Compulsory 1 year Experience in RA Key Responsibilities: Dossier Preparation & Review: Prepare, compile, and critically review regulatory dossiers (CTD/eCTD format) for submission in compliance with country-specific regulatory guidelines. Ensure completeness, accuracy, and quality of all submission documents. Query Management: Handle and respond to regulatory queries in a timely and efficient manner. Coordinate with cross-functional teams to gather required clarifications and documentation. Lifecycle & Project Management: Manage the end-to-end lifecycle of product registrations including new submissions, renewals, and variations. Track project timelines, regulatory milestones, and ensure on-time delivery of submissions. Regulatory Intelligence & Guideline Updates: Regularly monitor and interpret updates in country-specific regulatory guidelines. Ensure internal processes and documentation are aligned with the latest regulatory expectations. Cross-Functional & External Coordination: Liaise with third-party manufacturers to gather technical documents and compliance-related data. Collaborate with internal departments such as QA, QC, R&D, and Supply Chain for seamless documentation and query resolution. Countries of Regulatory Responsibility: Nigeria Zimbabwe Ukraine French West Africa (FWA) – Additional updates applicable Job Type: Full-time Pay: ₹15,000.00 - ₹30,000.00 per month Benefits: Leave encashment Provident Fund Work Location: In person
Job Description: Regulatory Affairs – Dossier Preparation & Lifecycle Management Requirement- Compulsory 1 year Experience in RA Key Responsibilities: Dossier Preparation & Review: Prepare, compile, and critically review regulatory dossiers (CTD/eCTD format) for submission in compliance with country-specific regulatory guidelines. Ensure completeness, accuracy, and quality of all submission documents. Query Management: Handle and respond to regulatory queries in a timely and efficient manner. Coordinate with cross-functional teams to gather required clarifications and documentation. Lifecycle & Project Management: Manage the end-to-end lifecycle of product registrations including new submissions, renewals, and variations. Track project timelines, regulatory milestones, and ensure on-time delivery of submissions. Regulatory Intelligence & Guideline Updates: Regularly monitor and interpret updates in country-specific regulatory guidelines. Ensure internal processes and documentation are aligned with the latest regulatory expectations. Cross-Functional & External Coordination: Liaise with third-party manufacturers to gather technical documents and compliance-related data. Collaborate with internal departments such as QA, QC, R&D, and Supply Chain for seamless documentation and query resolution. Countries of Regulatory Responsibility: Nigeria Zimbabwe Ukraine French West Africa (FWA) – Additional updates applicable Job Type: Full-time Pay: ₹15,000.00 - ₹30,000.00 per month Benefits: Leave encashment Provident Fund Work Location: In person