Kirthika Ravi
M.Pharmacy (Pharmaceutical Quality Assurance)
- Role
- Regulatory Affairs Executive at Medopharm
- Location
- Chennai, TN, IN
- LinkedIn followers
- 500 followers
About Kirthika Ravi
Seeking an opportunity with a reputed organization to leverage my expertise and skills in…
Experience
Regulatory Affairs Executive
Dec 2023 — Present · Chennai, IN
o CTD dossier preparation as per the current guidelines of the respective regulatory authorities of Emerging markets such as RoW countries (New Registration and Renewals).o Responsible for compiling /registration filings of pharmaceutical productso Client queries by providing the supportive documents and to fulfil the gap analysis in dossiers.o Handled query response to various Ministry of Healtho Prepared SmPC\'s, PIL for regulatory submissions as per the current prescribed guidelines of the respective regulatory authorities.o Review of Artwork as per labelling guidelines. o Handled Post approval changes and filed variations for extension of shelf life of the product. o Documentation and Data Management
Education
Sri Ramachandra Institute Of Higher Education and Research
Bachelor of Pharmacy - BPharm
2017 — 2021
Sri Ramachandra Institute Of Higher Education and Research
Master's degree
2021 — 2023
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