ECTD Global
Kiran Kumar Kondrakunta
Regulatory affaris
Bengaluru
Summary
Dynamic Regulatory Affairs Executive with a proven track record in Pharma field, adept in dossier preparation and regulatory compliance. Skilled in analytical research, showcasing a blend of hard skills like CMC document quality control and soft skills such as effective team collaboration. Achieved significant risk mitigation through multidisciplinary team coordination, enhancing product safety and regulatory success.
Overview
3
3
years of professional experience
6
6
years of post-secondary education
3
3
Languages
Work History
Regulatory Affairs Execeutive
Strides Pharma Science
Bengaluru
08.2024 - Current
- Prioritize project-related tasks to efficiently complete essential tasks.
- Review the CMC part of dossier for new filings and extension projects.
- Review and approve the MFR's, MPR's, SFG and FG records for new products and existing products.
- Perform CMC documents quality control checks to maintain compliance with company initiatives.
- Prepare and maintain document inventory for core dossier preparation.
- Prepare responses to agency queries and due diligence queries from customers.
- Evaluate proposed changes to products or manufacturing processes for potential impact on regulatory documents.
- Coordinated multidisciplinary review teams to evaluate product safety concerns, resulting in more informed decision-making and risk mitigation efforts.
- Work with internal team members to accomplish regulatory goals and achieve full compliance with all products.
Regulatory Affairs Officer II
MEDREICH
Bengaluru
10.2022 - 08.2024
- Preparation of Module-1, Module-2 and Module-3 dossier sections as per requirement of UK and European countries for both initial filing and variation filing purpose. Handling of respective health authority queries.
- Review of all CMC related documents like exhibit or intended process validation protocols and reports, Batch records, Specifications, Method of analysis (of FP, Drug substance, Excipients and Packaging materials), Justification of specifications, Stability protocols and Stability data as per regulatory requirement.
- Review of change controls and assess their impact on dossier and consequently plan for variation filing where impact is positive.
- Handled post-approval changes and variation filings related to Quality and Administrative changes and their respective Health authority queries.
- Prepared cover letters, eAF's, and other additional data & supporting documents in Module-1, updated dossier sections of Module-3 required for Type IA, Type IAIN, Type IB & Type II variation filings.
- Prepared justifications for major variations and few minor variation filings where ever applicable as per requirement.
- Compilation, Publishing and Validation of dossier using eCTD tool and Lorenz eValidator.
- Handled the variations related to the Batch size increase, Minor change in manufacturing process, Inclusion of additional FP manufacturing site & API manufacturer, Changes in Specification or MOA of API and Drug product, CEP revisions of API’s, Deletion of non-significant test parameters, Widening of FG specification limits, Pharmacopeial updates.
Junior Research Associate
Gland Pharma
Hyderabad
07.2021 - 09.2022
- Worked in Analytical Research & Development (Peptides–Characterization, Impurities quantification).
- Handled analytical instruments like HPLC, GC, IR, UV, Auto titrator & other minor instruments to analyze the developmental trail samples from Synthetic R&D.
- Enhanced research quality by conducting thorough literature reviews and data analysis.
- Preformed Analytical Method development trials and Method validation studies for Assay, Related substances and other Impurities in drug substance.
- Participated in regular meetings with project leads to discuss progress and identify areas for improvement or further investigation.
- Implemented quality control measures throughout research process, minimizing errors and enhancing overall study validity.
- Prepared high-quality reports detailing research outcomes, ensuring clear communication of results to stakeholders.
Education
Master of Science - Pharmaceutical Analysis
NIPER - Guwahati
Guwahati, India 08.2019 - 06.2021
Bachelor of Science - Pharmacy
Chalapathi Institute of Pharmaceutical Sciences
Guntur, India 08.2015 - 05.2019
Skills
Regulatory guidelines
ICH, MHRA, EMA, TGA
eCTD
Software
Trackwise
Lorenz eValidator
Timeline
Regulatory Affairs Execeutive
Strides Pharma Science
08.2024 - Current
Regulatory Affairs Officer II
MEDREICH
10.2022 - 08.2024
Junior Research Associate
Gland Pharma
07.2021 - 09.2022
Master of Science - Pharmaceutical Analysis
NIPER - Guwahati
08.2019 - 06.2021
Bachelor of Science - Pharmacy
Chalapathi Institute of Pharmaceutical Sciences
08.2015 - 05.2019
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