Shobha Singh
Regulatory Affairs Officer at KAISHA LIFESCIENCES Private Limited- Claim this Profile
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English Full professional proficiency
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Hindi Native or bilingual proficiency
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Gujarati Limited working proficiency
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Marathi Limited working proficiency
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Sindhi Elementary proficiency
Topline Score
Bio
Experience
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KAISHA LIFESCIENCES Private Limited
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India
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Pharmaceutical Manufacturing
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1 - 100 Employee
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Regulatory Affairs Officer
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Apr 2022 - Present
Preparation and Compilation of Dossiers as per CTD Guidelines. Handling of Sugam Portal and Queries received from regulatory bodies. Handling Vendor Qualification. Liasioning with Daman FDA for Licencing i.e Test Licence, Product Permission, COPP, Renewals, CT 10 etc. Reviewing and preparation of Artwork for New Projects. Review of documents received from various departments and group companies. Preparation and Compilation of Dossiers as per CTD Guidelines. Handling of Sugam Portal and Queries received from regulatory bodies. Handling Vendor Qualification. Liasioning with Daman FDA for Licencing i.e Test Licence, Product Permission, COPP, Renewals, CT 10 etc. Reviewing and preparation of Artwork for New Projects. Review of documents received from various departments and group companies.
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Amanta Healthcare Ltd.
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India
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Pharmaceutical Manufacturing
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100 - 200 Employee
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Regulatory Affairs Officer
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Feb 2021 - Apr 2022
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Chemilines Healthcare India Private Limited
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Ahmedabad, Gujarat, India
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Regulatory Affairs Executive
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Aug 2019 - Jan 2021
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Education
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2017 - 2019
Gujarat Technological University, Ahmedbabd
Master's of pharmacy, Pharmaceutics -
2017 - 2019
Rofel Shri G.M.Bilakhia College of Pharmacy , Vapi
Masters of pharmacy, Phramaceutics -
2014 - 2017
Rofel Shri G.M.Bilakhia College of Pharmacy , Vapi
Bachelor of Pharmacy - BPharm
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