Deeksha Mohite
Senior Regulatory Affairs Specialist
- Role
- Senior Regulatory Affairs Specialist at Smiths Medical
- Location
- Thane, IN
- LinkedIn followers
- 500 followers
About Deeksha Mohite
6+ years of experience in regulatory process and approvals involving documentation…
Experience
Senior Regulatory Affairs Specialist
Dec 2022 — Present · Borivali, IN
1 Medical devices A, B, and C registration on CDSCO portal to import devices inIndia.2 Market Standing and Non-conviction certificates.3 Support the India specific label requirement, tender submission, Legalmetrology requirement etc.4 Collate and share adequate information with Distributor for registration ofcompany devices in Greater India (Sri Lanka and Bangladesh).5 Update with current regulations.6 Working on NSWS portal.7 Post Approval applications for Indian authorized agent address change,Addition of SKUS, etc.8 Regulatory Strategies & to provide local regulation intelligence to internalstakeholders.9 Maintain Registration and follow up with the DCGI & CDSCO regulatory portaland authorities.10 Support the Regulatory prices related subjects in collaboration withcommercial.11 NPPA submissions to support regulatory prices related to LMPC.12 Voluntary registrations of Class A non-sterile and non-measuring devices.13 Processing MD-42 license (whole sale drug license) for office and warehouse.
Education
Ramniranjan Jhunjhunwala College (Autonomous)
Post Graduate Diploma, Regulatory Affairs
2019 — 2020
Smt. Sulochanadevi Singhania School, Thane
10th, ICSE
2010 — 2011
Shri Shankar Shetty Jr. College, Thane
12th, Science
2012 — 2013
Guru Nanak Khalsa College of Arts Science & Commerce, Matunga
Master of Science - MS, Five Years Integrated MSc. Course in Bioanalytical Sciences
2016 — 2018
Guru Nanak Khalsa College of Arts, Science & Commerce, Matunga
Bachelor of Science - BS, Five Years Integrated MSc. Course in Bioanalytical Sciences
2013 — 2016
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