Shivakumar Gb
Veeva Vault RIMs | PLCM | Variations | CMC | Dossier Compilation | Change control assessment
- Role
- Sr Regulatory Affairs Associate at Parexel
- Location
- Bengaluru, KA, IN
- LinkedIn followers
- 500 followers
About Shivakumar Gb
Profile summary: Years of experience: 12 Years Authoring and Submitting of…
Experience
Sr Regulatory Affairs Associate
Nov 2020 — Present · IN
Veeva vault RIM: CMC submission management in Veeva RIM for global markets, including the management of registration data and creation of submission, RFI and HA commitment records within the Veeva RIMS.Extracting the Veeva reports-Impact assessment reports, Manufacturing name of DS, DP and Packaging.Worked in Data Remediation project for updating the MSNC variation.Expert in creation and management of Submission Content Plan (SCP) and HAQs. Change control assessment and building variation strategy for global markets.Handling International CMC variation: Submitting the EU core package by adding ancillary documents as per regional documentation.Life cycle submission management: Timely dispatch of submission by coordinating with affiliate/project manager and publisher.Carrying out publishing activity using the insight publisher and validating using EURS and Lorenz validatorDispatching the submission to health authority through CESP gateway.Archiving and dispatching the submission to local affiliate using Veeva vault RIM.
Education
Rajiv Gandhi University of Health Sciences
Bachelor of Pharmacy, Pharmacy
2005 — 2009
Rajiv Gandhi University of Health Sciences
Master's degree, Pharmaceutics
2010 — 2012
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