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
Experienced in Word, Excel, and PowerPoint
XML data management
Skilled in Adobe PDF tools
Familiarity with artwork management systems
Regulatory database management
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