Ganesh Shinde

Driven International Regulatory Affairs / Ensuring Product Safety and Compliance for ROW Market

Role
Regulatory Affairs Executive at Zyphar\'s Pharmaceutics Private Limited
Location
Pune, MH, IN
LinkedIn followers
500 followers

About Ganesh Shinde

I\'m a Regulatory Affairs professional with a strong background in dossier preparation and compliance for pharmaceutical products across ROW countries. I specialize in simplifying complex regulatory processes, ensuring timely approvals, and fostering strong relationships with authorities. My passion lies in driving global success by maintaining the highest quality and compliance standards for pharmaceutical products.\"

Experience

  1. Regulatory Affairs Executive

    Zyphar\'s Pharmaceutics Private Limited

    Apr 2025 — Present · Pune, IN

    Dossier preparation and regulatory submissions (CTD/ACTD/ Country specific formats for ROW markets)2. Regulatory document handling and lifecycle management3. Artwork review and approval as per regulatory requirements4. Technical regulatory support to Business Development team5. Audit and compliance support (ISO, WHO GDP, WHO GMP)6. Sample coordination for product registration7. Client regulatory queries handling8. Market complaint handling and regulatory coordination

Education

  • Latur collage of pharmacy, Hasegaon

    B pharmacy

    2018 — 2022

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Ganesh Shinde — Regulatory Affairs Executive at Zyphar\'s Pharmaceutics Private Limited in Pune, MH, IN | Unifers