Regulatory Coordinator
1 day ago
Your responsibilities include, but are not limited to:• Independently manage and prepare routine Health Authority submissions including Annual Reports, DSUR, New Protocol Submissions, Protocol Amendment , and New Investigator Submissions to ensure timely submissions in accordance with the FDA regulations• Contribute to Module #1 documents including FDA forms and cover letters for maintenance/non-maintenance submissions with management oversight• Conduct monthly reconciliation to ensure timely submissions are in accordance with FDA regulations as well as meeting all Novartis requirements for submission-related activities• Proactively identify issues, gaps, and trade-offs affecting optimal and timely submission. Independently manage US regulatory compliance activities, including timely review and updates to product specific information as provided by program team representative into a compliance database (DRAGON), when applicable• Independently manage the user fee registration requests. Independently manage and execute drug shipment ticket review process (US)• In addition to regulatory manager, provide guidance to clinical functions on regulatory compliance activities, such as requirements for TOOs, VDRs, drug shipment etc. • Assist regulatory managers to support compilation and release of submissions to regulatory agencies as well as submission-related activities for regulatory responses to health authorities• Where appropriate, participating in kick-off meetings for NDA/IND annual reports and QC of NDA annual reports from previous versions (US). Where appropriate, perform QC of approved label versus previous versions with adequate management oversight
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Regulatory Coordinator
22 hours ago
Hyderabad, India Novartis Full time387033BR **Regulatory Coordinator**: India **About the role** Your responsibilities include, but are not limited to: - Support regulatory compliance activities, including entering product specific attributes as provided by program team representative into Regulatory Information Management System (RIM) (e.g. DRAGON). Provide support as needed for routine...
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Regulatory Coordinator
5 days ago
Hyderabad, Telangana, India Novartis Full time26 major approvals. 13 major submissions. 2,000 associates worldwide. That was Regulatory Affairs in 2020. We are a culturally diverse, global team of talented professionals seeking to leverage the voices of our patients in our approach to bringing potentially life-changing therapies to people who need them. Novartis has a robust pipeline, including possible...
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Regulatory Coordinator
4 days ago
Hyderabad, Telangana, India Novartis Full time ₹ 6,00,000 - ₹ 18,00,000 per yearSummaryContributes and support the development of submission of product registration, progress reports, supplements, amendments, and/or periodic experience reports. Supports all registration activities of the Department to ensure compliance with the requisites of the local pharmaceutical regulatory environment.About the RoleKey ResponsibilitiesEnsure...
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Regulatory Coordinator
4 days ago
Hyderabad, Telangana, India Novartis Full timeSummary Contributes and support the development of submission of product registration progress reports supplements amendments and or periodic experience reports Supports all registration activities of the Department to ensure compliance with the requisites of the local pharmaceutical regulatory environment Key Responsibilities Ensure procurement of various...
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Regulatory Coordinator
6 days ago
Hyderabad (Office), India Novartis Full time ₹ 12,00,000 - ₹ 36,00,000 per yearJob Description SummaryContributes and support the development of submission of product registration, progress reports, supplements, amendments, and/or periodic experience reports. Supports all registration activities of the Department to ensure compliance with the requisites of the local pharmaceutical regulatory environment.Job DescriptionKey...
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Regulatory Specialist
1 week ago
Hyderabad, India MSN Laboratories Full timeWe are seeking a highly organized and detail-oriented Regulatory Project Coordinator/Manager to be the central point of contact between our Head Office (HO) and our Emerging Market country teams. This critical role ensures the seamless and timely delivery of all regulatory, technical, and administrative documentation required for product registration,...
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Regulatory Specialist
7 days ago
Hyderabad, India MSN Laboratories Full timeWe are seeking a highly organized and detail-oriented Regulatory Project Coordinator/Manager to be the central point of contact between our Head Office (HO) and our Emerging Market country teams. This critical role ensures the seamless and timely delivery of all regulatory, technical, and administrative documentation required for product registration,...
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Regulatory Specialist
7 days ago
Hyderabad, India MSN Laboratories Full timeWe are seeking a highly organized and detail-oriented Regulatory Project Coordinator/Manager to be the central point of contact between our Head Office (HO) and our Emerging Market country teams. This critical role ensures the seamless and timely delivery of all regulatory, technical, and administrative documentation required for product registration,...
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Regulatory Specialist
1 week ago
Hyderabad, India MSN Laboratories Full timeWe are seeking a highly organized and detail-oriented Regulatory Project Coordinator/Manager to be the central point of contact between our Head Office (HO) and our Emerging Market country teams. This critical role ensures the seamless and timely delivery of all regulatory, technical, and administrative documentation required for product registration,...
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Regulatory Specialist
5 days ago
Hyderabad, India Whatjobs IN C2 Full timeWe are seeking a highly organized and detail-oriented Regulatory Project Coordinator/Manager to be the central point of contact between our Head Office (HO) and our Emerging Market country teams. This critical role ensures the seamless and timely delivery of all regulatory, technical, and administrative documentation required for product registration,...
