Sagar K.
Senior Associate in Regulatory Affairs Department at TCS Pune.
- Role
- Senior Associate in Regulatory Affairs at Tata Consultancy Services
- Location
- Pune, MH, IN
- LinkedIn followers
- 500 followers
About Sagar K.
I have total 3+ years of experience in regulatory document processing, submission and publishing also 1 year of relevant experience in CRO.Experienced in followings Tools: •Document Management Tools:RDMS (Regulatory Documents Management System),RIMS - Veeva Vault (Content Management and Publishing),Outlook, MS Teams, iTrack, MS PPT,Adobe Acrobat Pro, DC and Standard (ToolBox - ISI Tools),MS Word, MS Excel, Word Ribbon, DocXtools, DP Macros, InteliNotion,Workshare Compare, APDFPR Unlocking,EndNote - Reference Tool•Submissions Tools:LORENZ Docu-bridge (Document Publishing), Insight Publisher,ESG-FDA Gateway Submission•Task Manager Tools:GRASP (Global Regulatory Affairs Submission Planner)•Submission Viewer:Insight Viewer,LORENZ e-Validator,GS Viewer,GS Validator•Awarded with Rewards and Recognition of outstanding contributions towards DP at TCS in 2023.•Four Pharmaceutical paper publications in different Journal.•Winner of Singing Competitions in extracurricular activity.•Posture Paper Presentation on \"Modified Pear Starch as Novel Super Disintegrating Agent: Development and Evaluation” in International Conference on “Emerging Trands in Delivery of Phytoconstituents and Ethnopharmacolgy – Validation of Traditional Medicine-II” at PCOP 29th- 30th November 2019.•Certificate of Lifetime Membership (INDIAN PHARMA EDUCATIONAL SOCIETY) IPES (Registration No. UP/2018/6435).
Experience
Senior Associate in Regulatory Affairs
Mar 2022 — Present · Pune, IN
To Process/Formatted for Publishing of e-CTD Documents Modules 1 to 5, IMPD, IND-IMPD Conversion, IB, PSUR, PBRER, PADER, DSUR, CSP, CSR, NCD, CRF, RMP, Protocol Amendment, Protocol Comparison, IB Comparison, ICF, Word Formatting, PDF’s Publishing and EndNote References.
Education
Kamla Nehru College of Pharmacy Butibori, Nagpur
Bachelor of Pharmacy, Pharmacy
2014 — 2018
Smt Kishoritai Bhoyar College of Pharmacy, Kamptee
Master in pharmacy, Pharmacy
2018 — 2020
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