Prathamesh Mali

Apprentice – Plant Regulatory Affairs, Bridging Manufacturing Operations and Regulatory Requirements.

Role
Apprentice - Plant Regulatory Affairs at Bharat Serums and Vaccines Limited
Location
Thane, MH, IN
LinkedIn followers
500 followers

About Prathamesh Mali

Plant Regulatory Affairs professional bridging manufacturing operations with regulatory strategy to support global regulatory submissions, with focus on CTD Module 3 (CMC). Utilize direct exposure to manufacturing processes, batch documentation, and plant technical data to contribute to CMC documentation including manufacturing process descriptions, flowcharts, In process controls, qualitative and quantitative compositions, and other technical information derived from site operations, ensuring alignment of manufacturing activities with regulatory submission requirements and global compliance standards.

Experience

  1. Apprentice - Plant Regulatory Affairs

    Bharat Serums and Vaccines Limited

    Jan 2026 — Present · Thane, IN

    Plant Regulatory Affairs professional bridging manufacturing operations with regulatory strategy to support global regulatory submissions, with focus on CTD Module 3 (CMC). Utilize direct exposure to manufacturing processes, batch documentation, and plant technical data to contribute to CMC documentation including manufacturing process descriptions, flowcharts, qualitative and quantitative compositions, and other technical information derived from site operations, ensuring alignment of manufacturing activities with regulatory submission requirements and global compliance standards.

Education

  • Shivaji University, Kolhapur

    Masters in Pharmacy, Pharmaceutical Sciences

  • Shivaji University, Kolhapur

    Bachelor of Pharmacy, Pharmaceutical Sciences

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Prathamesh Mali — Apprentice - Plant Regulatory Affairs at Bharat Serums and Vaccines Limited in Thane, MH, IN | Unifers