Rupali Bundele
Regulatory Affairs Officer at Encube Ethicals Private Limited- Claim this Profile
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Bio
Experience
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Encube Ethicals Private Limited
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India
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Pharmaceutical Manufacturing
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300 - 400 Employee
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Regulatory Affairs Officer
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Jul 2022 - Present
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Althea Pharma 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 Associate
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Feb 2021 - Jul 2022
1. Compilation of CTD, ACTD & Country specific dossiers, reviewing documents required for dossiers submissions, query reply raised by customers & authorities. 2. Co-ordinating with the plant for required documents. Arrangement of dossier samples, product samples, from plant or third party. 3. Prepared and compiled MOCK-UP, SPC, and leaflets along with product details list. 4. Respond to deficiencies/queries received from MOH or country consultants. 1. Compilation of CTD, ACTD & Country specific dossiers, reviewing documents required for dossiers submissions, query reply raised by customers & authorities. 2. Co-ordinating with the plant for required documents. Arrangement of dossier samples, product samples, from plant or third party. 3. Prepared and compiled MOCK-UP, SPC, and leaflets along with product details list. 4. Respond to deficiencies/queries received from MOH or country consultants.
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sapphire Life sciences pvt.Ltd
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palghar
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Graduate Trainee
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Apr 2017 - Jun 2017
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Education
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Dr. Bhanubhen Nanavati College of Pharmacy
Master of pharmacy, Quality Assurance -
Aldel Education Trusts St John Institute of Pharmacy At Vevoor Palghar Tal Palghar Dist Thane
Bachelor of Pharmacy, Analytical Chemistry