Rupali Bundele

Regulatory Affairs Officer at Encube Ethicals Private Limited
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Contact Information
us****@****om
(386) 825-5501
Location
Mumbai, Maharashtra, India, IN

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Experience

    • India
    • Pharmaceutical Manufacturing
    • 300 - 400 Employee
    • Regulatory Affairs Officer
      • Jul 2022 - Present

    • India
    • Pharmaceutical Manufacturing
    • 1 - 100 Employee
    • Regulatory Affairs Associate
      • 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.

    • Graduate Trainee
      • Apr 2017 - Jun 2017

Education

  • Dr. Bhanubhen Nanavati College of Pharmacy
    Master of pharmacy, Quality Assurance
    2018 - 2020
  • Aldel Education Trusts St John Institute of Pharmacy At Vevoor Palghar Tal Palghar Dist Thane
    Bachelor of Pharmacy, Analytical Chemistry
    2014 - 2018

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