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About the Role
Major accountabilities:
- Major Accountabilities (Describe the main results of the role to be achieved)1. Provide operational support to Health Authority submissions including Annual Reports, DSUR, Recent Protocol Submissions, Protocol Amendment , and New Investigator Submissions to ensure timely submissions in accordance with the FDA regulations2. Conduct monthly reconciliation to ensure timely submissions are in accordance with FDA regulations as well as meeting all Novartis requirements for submission-related activities (Eg. TOOs, VDRs, drug shipment ticket review (US)).3. Support regulatory compliance activities, including timely review and updates to product specific information as provided by program team representative into a compliance database (DRAGON), when applicable4. Assist regulatory managers to support compilation and release of submissions to regulatory agencies as well as submission-related activities for regulatory responses to health authorities5. In collaboration with the clinical/regulatory teams, compile, integrate and publish clinical/regulatory documents with word processing, electronic publishing using publishing software and archive in the document management systems.6. Maintain basic knowledge of current electronic publishing standards, regulatory guidelines, and legal requirements.7. Support regulatory compliance activities,
including entering product specific attributes as provided by program team representative into Regulatory Information Management System (RIM) (e.g. DRAGON).8. Provide support as needed for routine Health Authority (HA) submissions including Periodic Reports, Renewal, Portfolio transformation (PT) Submissions (non-EU countries), New Product Planning (NPP) (non EU countries) etc. and procurement of registration samples and certificates, to ensure accurate and timely submissions to HAs.
Key performance indicators:
- 1. Timely tracking and reconciliation of routine submissions performed.
- 1. Timely completion of compliance activities and tracking.
- 1. Timely completion of Drug Shipping Process (US).
- 1. Timely completion of FDA forms and cover letters for CTD Module #1for maintenance submissions
- 1. Timely approval of Clinical Supplies/Labels.6. Completion of all assigned trainings
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