Summary
Overview
Work History
Education
Skills
References
Timeline
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KALAVATHI BADE

Windsor,Canada

Summary

With 15 years of experience in pharmaceutical regulatory affairs, quality control, and quality assurance, I specialize in developing and managing robust quality management systems to ensure compliance with global regulatory standards.

Overview

17
17
years of professional experience

Work History

Quality Assurance Specialist

Nutrameltz Inc.
12.2023 - 08.2024
  • Evaluated NPN labels for Canada and supplemental facts for U.S. market.
  • Drafted and filed Natural Health Product license applications with NNHPD.
  • Performed systematic internal evaluations to identify areas of non-compliance.

Regulatory Affairs Manager

Annora Pharma Pvt. Ltd.
05.2021 - 08.2023
  • Compile, technically review, and submit ANDA/ANDS/MAA packages following Food and Drugs Regulations, Health Canada, and EU standards in eCTD format.
  • Address regulatory agency queries and develop and implement complex regulatory submission strategies to maintain compliance across global markets (US, EU, Canada).
  • Conduct regulatory impact assessments on CMC changes and ensure adherence to FDA, EMA, and Health Canada guidelines.
  • Review and assess Change Controls, Laboratory Incidents, Deviations, OOS (Out-of-Specification), and OOT (Out-of-Trend) documentation for accuracy and compliance.
  • Collaborate with internal teams and external partners to meet global regulatory requirements.
  • Developed and implemented regulatory strategies to meet corporate objectives.
  • Performed periodic reviews of existing regulations and proposed changes.

Regulatory Affairs Manager

Jodas Expoim Pvt. Ltd.
01.2018 - 05.2021
  • Review of Process Validation, Dissolution Profiles, Stability/Photo-stability, Analytical Method Validation, BET, Sterility, and compatibility protocols and Finished product (FP), Raw material, and Packaging material specifications in line with pharmacopeias and regulatory guidelines.
  • Assess ASMF/DMF for regulatory compliance.
  • Reviewed comprehensive technical documentation for medical device approvals.

Quality Control Team Member

Micro Labs Ltd., & Dr. Reddy's Laboratories
09.2007 - 12.2017
  • Performed inspections on incoming materials and components to ensure compliance with established standards.
  • Review and compilation of stability data, and identification of out-of-trend results.
  • Supported laboratory investigations, change controls, and CAPAs, providing guidance and coaching to the Quality Control team, and assisting with regulatory inspections.
  • Conducted analysis of finished products and stability samples, IQ/OQ/PQ, and calibration of laboratory instruments, ensuring compliance with quality standards.
  • Prepared risk assessment reports for various instruments to identify and mitigate potential issues.

Education

Project Management -

St. Clair College
Windsor, Canada
04-2025

Masters in Biotechnology -

Barati Dasan University
Tamil Nadu, India

Skills

  • ANDA/ANDS/MAA
  • Authoring Dossier
  • Injectables, OSD
  • Post Approvals
  • Agile Methodologies
  • Internal Audits and Inspections
  • CMC
  • Query Response
  • Medical Devices

References

References available upon request.

Timeline

Quality Assurance Specialist

Nutrameltz Inc.
12.2023 - 08.2024

Regulatory Affairs Manager

Annora Pharma Pvt. Ltd.
05.2021 - 08.2023

Regulatory Affairs Manager

Jodas Expoim Pvt. Ltd.
01.2018 - 05.2021

Quality Control Team Member

Micro Labs Ltd., & Dr. Reddy's Laboratories
09.2007 - 12.2017

Project Management -

St. Clair College

Masters in Biotechnology -

Barati Dasan University

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