Summary
Overview
Work History
Education
Skills
Disclaimer
Timeline
OfficeManager
Hemanth kumar Bandaru

Hemanth kumar Bandaru

3 years 6 months of experience in Pharma (Injectables) Regulatory Affairs Department Skilled in CMC documentation of Pre and Post Approval, eCTD submissions, and ensuring compliance with FDA and ICH guidelines
Hyderabad,TG

Summary

To associate myself with an organisation that provides me an opportunity to use my professional knowledge, technical skills and interpersonal skills to be part of a team that works dynamically towards the growth of the organisation.

Successful Executive with over 3 years & 6 months of demonstrated ability in delivering mission-critical results. Offering outstanding communication and cross-cultural team management skills. Entrepreneurial attitude for optimal profitability. Ambitious team leader adept at creating strategic alliances with organizational leaders and effectively aligning with and supporting key business initiatives.

Overview

3
3
years of professional experience
4070
4070
years of post-secondary education

Work History

Executive

Sterimax Inc.
03.2025 - Current
  • Working as Executive in Regulatory Affairs Department in Sterimax Inc.
  • Create, validate, and publish eCTD sequences using Lorenz DocuBridge.
  • Ensure proper hyperlinking, bookmarking, and XML backbone generation as per Health Canada eCTD specifications.
  • Respond to Health Canada queries, screening deficiency notices, and clarification requests.
  • Compile and submit ANDS dossiers for sterile injectable products in eCTD format.


Executive

Biological E Limited
10.2022 - 03.2025
  • Working as Executive in Regulatory Affairs Department in Biological E Limited since October 2022 to March 14th, 2025.
  • Compile and review ANDA submissions for sterile injectable products in eCTD format.
  • Ensure completeness and accuracy of Modules 1–3, especially CMC sections & Coordinate with formulation and analytical teams to gather data on manufacturing processes, control strategies, and stability studies.
  • Respond to FDA queries, deficiency letters, and Complete Response Letters (CRLs).
  • Prepare and submit post-approval supplements (PAS), Changes Being Effected (CBE-30, CBE-0), and Annual Reports for changes in manufacturing, packaging, testing, or labeling.


Education

Master of Science - Pharmaceutical Sciences

Osmania Technological University
Hyderabad, India
04.2001 - 10.2022

Intermediate - Botany Zoology Chemistry

Board of Intermediate Education

S.S.C. - Sciences

Board of Secondary Education

Bachelor of Science - Pharmacy

Marri Laxman College of Pharmacy
Hyderabad, India
04.2001 - 08.2020

Skills

Experienced with Lorenz docuBridge

Disclaimer

I hereby declare that all the information provided above is true to the best of my knowledge. Signature: Bandaru Hemanth Kumar

Timeline

Executive

Sterimax Inc.
03.2025 - Current

Executive

Biological E Limited
10.2022 - 03.2025

Master of Science - Pharmaceutical Sciences

Osmania Technological University
04.2001 - 10.2022

Bachelor of Science - Pharmacy

Marri Laxman College of Pharmacy
04.2001 - 08.2020

Intermediate - Botany Zoology Chemistry

Board of Intermediate Education

S.S.C. - Sciences

Board of Secondary Education

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Hemanth kumar Bandaru3 years 6 months of experience in Pharma (Injectables) Regulatory Affairs Department Skilled in CMC documentation of Pre and Post Approval, eCTD submissions, and ensuring compliance with FDA and ICH guidelines