Regulatory Officer
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Post Graduate in Biotechnology and 1 year of Experience in Regulatory Affairs.
I am responsible for ensuring compliance with regulatory requirements and guidelines. Effectively analyzed and evaluated regulatory submissions for accuracy, ensuring compliance with all applicable regulations according to CTD & ACTD formats. The principles of regulatory affairs and submission requirements according to international guidelines of Different countries of North America, South America & Asia.
Coordinated with internal departments such as Quality Assurance, Quality Control, Manufacturing and Production while preparing global registration documents for new products.
Documents & Dossiers, after Complete Review Submit to different countries like Equador, Chile, Costa Rica, Guatemala, Honduras, Cambodia etc.,
Masters of Science in Biotechnology
3 Months Bachelors Project work - “Isolation and Identification of Microbial Flora in Air in Different Areas of Agra Regions”
6 Months Masters Project work - “Comparative Study of Widal Test and Typhidot Test in Typhoid Fever Patients”
