Vivitha Thangaraj
Regulatory Affairs Analyst | Bangalore | CDSCO & Global Submissions (APAC, LATAM, CEMA) | Enabled 40% Faster Market Access for Medical Devices
- Role
- Regulatory Affairs Analyst at Alcon
- Location
- Chennai, IN
- LinkedIn followers
- 500 followers
About Vivitha Thangaraj
Hi, I\'m Vivitha Thangaraj, a passionate Regulatory Affairs professional with 3.5 years of…
Experience
Regulatory Affairs Analyst
May 2024 — Present · Bengaluru, IN
India Regulatory Affairs SpecialistEnd-to-End Regulatory OwnershipLed the complete lifecycle for India submissions — including new registrations, post-approval changes, renewals, tender submissions, and query responses — ensuring timely approvals and business continuity. CDSCO & e-SUGAM ExpertiseManaged Import Licenses, RCs, and variations through the e-SUGAM portal with a 100% success rate, maintaining full compliance with CDSCO and NPPA regulations.Accelerated Approval TimelinesOptimized documentation workflows and stakeholder coordination to reduce approval timelines by 20–30%, enhancing market readiness.Audit-Ready Compliance & Risk MitigationMaintained up-to-date licenses, proactively tracked regulatory changes, and ensured zero audit observations through robust documentation practices.Cross-Functional Regulatory CollaborationEffectively collaborated with global RA leads, supply chain, and commercial teams to deliver accurate, on-time submissions and resolve HA queries under tight deadlines.
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