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Mayuri Shinde
Regulatory Affairs- Operations @Ecolab
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WORK HISTORY
Regulatory Affairs- Operations @Ecolab
Gurugram, IN
Prepared regulatory query responses for submission of Import, SND (Subsequent New Drug), and Renewal applications for India market.Drafted Country-Specific Reg-In Reports, which summarize regulatory requirements and registration status for Ecolab products across various regions.Utilized Regl’Anios tool to resolve order-blocking issues by ensuring compliance with country-specific regulatory requirements.Reviewed product labels using ADB Database and downloaded approved versions for verification and submission.Retrieved product information using the Biocide Database to support documentation and product registration needs.Accessed and downloaded product Safety Data Sheets (SDS) via MSDS tools for regulatory and internal use.Coordinated with local Indian regulatory authorities for submissions and compliance matters.Actively participated in weekly global regulatory meetings covering APAC and IMEA regions to align with cross-country requirements and updates.Currently contributing to Project Mirror, a key Ecolab initiative transitioning products from sterile to non-sterile formats. Responsible for end-to-end label review and compliance.
EDUCATION
Marathwada Mitramandal College of Pharmacy Thergao, Pune
Master of Pharmacy
Vilasrao Deshmukh Foundation
Bachelor of Pharmacy
ABOUT MAYURI SHINDE
I am a Regulatory Affairs professional with 1.4 years of hands-on experience in preparing dossiers and documentation across CTD, ACTD, and non-CTD formats. I bring expertise in:Prepration of Modules 2.3 to 2.7, Module 3, 4, and 5 Preparation of PSUR, PBRER, and Risk Management Plans (RMP) to ensure compliance.Patient Information Leaflet (PIL) and Master Product Information (MPI) creation using Innovator\'s SmPC as a reference.Managing excipient safety by analyzing the Master Formula Record (MFR) of diverse products.I am passionate about ensuring smooth regulatory processes and maintaining high standards of quality and compliance. Open to new opportunities and available for immediate joining.\"
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