Santosh Ghule

About Santosh Ghule

Success occurs when you\'re Dreams\" Get bigger than you\'re excuses.\"

Experience

1. Regulatory Affairs Executive

   USV PRIVATE LIMITED

   Dec 2024 — Present · Mumbai, IN

   Prepare and publish e-CTD dossiers, and submit them to EU Health Authorities through MRP/DCP/RUP/National procedures (via CESP/MHRA portal).*Collate, prepare, and accurately file dossiers for pharmaceutical formulations to secure timely approvals from various EU/UK Health Authorities.*Resolve queries received from agencies within their stipulated timeframes.*Evaluate any proposed post-approval changes. Prepare and file applicable variations, articles, or annual reports to ensure regulatory compliance (Post-approval Life Cycle Management).*Review and conduct regulatory assessments of change controls, coordinating with CFTs.*Collate and conduct a first-level review/overview of relevant standard technical documentation, including PDR, AMV, Specifications, SAP, Stability, PVR, and BMRs.*Conduct an initial review of the specifications for APIs/Semi-Finished Products/API notifications, ensuring compliance with regulatory requirements.*Conduct an initial review of labelling/artwork, ensuring adherence to EMA/MHRA guidance.*Prepare Tech-packs for the Approval Package and share copies of all agency submissions pertaining to the Finished Product (FP) Approval package with respective CFTs. Customer MAH support:*Prepare dossiers and variation packages for customer Marketing Authorization Holders (MAHs), share them via the specific organizational domain, and assist in reviewing queries received from customer MAHs.*Review change controls/notifications and share them with the customer for their approval and assessment.

Education

• Shivaji University, Kolhapur

  Bachelor of Pharmacy

• Shivaji University

  Master of Pharmacy