Vinay Thandra
Regulatory strategy & compliance | Novartis | Labelling, Clinical & CMC | Ex- Aurobindo | NIPER-H
- Role
- Regulatory Affairs Specialist at Novartis
- Location
- Hyderabad, TG, IN
- LinkedIn followers
- 500 followers
About Vinay Thandra
Preparation and Review of Dossier for ANDS, DINA, DNF and SANDS submissions.• Responsible for documentation, review and compilation of Quality (CMC), labelling and Clinical modulesdocuments for Initial submissions.• Review and finalization of artworks (Labels and Leaflet) and labelling related documents for Initialand Post Approval Changes submissions. • Actively involved in preparation of response to queries raised by Regulatory Authorities in accordance with the agency timelines. • Review and Compilation of Clinical Study Reports and Bio analytical Study Reports and Preparation of Summary Reports of Clinical and Bio analytical Studies.• Supporting GPVD (Pharmacovigilance) team for preparation PSUR (Annual Reports) by providing recently updated Safety information in Product Monograph.• Initiating timely work order revisions for post approval changes for labels and or leaflet revisions. • Reviewing and finalizing the work order launches of artworks (Commercials).• Co-ordination with Internal and external Stakeholders such as cross Functional Teams (FR & D GPVD, IPR, PD, SCM, BD and CROs) and Onsite personnel • Preparation and filing of Supplementary submissions and Annual Notifications for labelling changes• Documenting and finalization of REP (Regulatory Enrolment Process) files for Health Canada Submissions. • Updating the Approval Information, Post Approval Changes Life cycle Management using the AGILE (Oracle), Pharma Ready (e-CTD Tool).
Experience
Regulatory Affairs Specialist
Jul 2022 — Present · Hyderabad, IN
Education
National Institute of Pharmaceutical Education and Research
M.S (pharm)
2015 — 2017
Talla Padmavathi College of Education, Orus,Kareemabad, Warangal
Bachelor of Pharmacy - BPharm
2011 — 2015
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