INTERNSHIP DETAILS

RA GRSSC Interns

CompanyNovartis
LocationHyderabad
Work ModeOn Site
PostedAugust 4, 2026
Internship Information
Core Responsibilities
The intern will provide operational support for health authority submissions, including annual reports and protocol amendments, to ensure compliance with FDA regulations. They will also assist in compiling and publishing clinical documents while maintaining regulatory information in internal databases.
Internship Type
full time
Company Size
86787
Visa Sponsorship
No
Language
English
Working Hours
40 hours
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About The Company
Novartis is an innovative medicines company. Every day, working to reimagine medicine to improve and extend people’s lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach more than 250 million people worldwide. Find out more at https://www.novartis.com See our community guidelines: https://go.novartis.social/3Nboxki
About the Role

Job Description Summary

-To be used only for Intern or Student positions. Please enter specific details in the Additional Specifications Details field


 

Job Description

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, New 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.
  • 2. Timely completion of compliance activities and tracking.
  • 3. Timely completion of Drug Shipping Process (US).
  • 4. Timely completion of FDA forms and cover letters for CTD Module #1for maintenance submissions
  • 5. Timely approval of Clinical Supplies/Labels.6. Completion of all assigned trainings


 

Skills Desired

Key Skills
Regulatory AffairsClinical DocumentationRegulatory ComplianceData ReconciliationElectronic PublishingDocument ManagementFDA RegulationsRegulatory Information ManagementClinical SuppliesRegulatory Submissions
Categories
HealthcareScience & ResearchAdministrative