Experience

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  Indian biomedical skill consortium

  Aug 2023 - Oct 2023

  Intern

  ✓ Industrial exposure over Medical Device and Medical Equipment manufacturing sites.✓ Earned Certification in Biomedical Engineering (NSQF Level 5).✓ Skilled in developing Process SOPs, SMFs, and DHFs for medical devices, with knowledge of handling medical equipment and a solid understanding of ISO 13485, ISO 9001, ISO 14971, IEC 60601-1 standards, and IMDR 17.✓ Assisted in ensuring regulatory compliance and maintaining legal requirements for GMP certification, contributing to a 15% improvement in compliance audit outcomes. Show less

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  Clinchoice

  Jan 2024 - now

  Trainee - regulatory operations

  Contracted to Client - Pfizer Global Regulatory Sciences, Chennai as Associate - Regulatory Change Manager. ✓Contribute to Module 1, 2, and 3 documents for global CMC submissions across multiple drug products and medical devices. Plan and execute submissions in TrackWise, ensuring readiness in GDMS. ✓Prepare and format CMC content submissions in compliance with regulatory standards and ICH guidelines for eCTD, paper, and NEES formats using the Pfizer Regulatory Electronic Document Intelligent Content Template. Collaborate with Hub submission management and regulatory country officers to publish CMC packages, managing content in the Product Dossier Manager. ✓Act as the primary operational interface for clients and vendors across different time zones, demonstrating effective workload management through collaborative meetings and a dynamic framework. Show less