Regulatory Coordinator

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