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
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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