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
Qualification & Experience
Minimum of 3 years pharmaceutical experience with a minimum of 1-2 years of regulatory experience preferred.