Phani Varma Kalidindi
Lakeland,FL
Summary
Detail-oriented Regulatory professional with working experience in Quality, Regulatory and Clinical Research departments.
Overview
6
6
years of professional experience
1
1
Certification
Work History
Contract Quality Control Analyst
Agenus Inc
11.2023 - 03.2024
- Performed environmental monitoring including air viable, surface viable and total particulate during routine monitoring and dynamic fill/finish procedures.
- Conducted Endotoxin and LAL testing in accordance with organization policies.
- Conducted Gram staining on environmental monitoring samples to check for type of bacterial contamination of work place and made sure it is clean for batch production.
- Conducted personnel monitoring on manufacturing team personnel to check of contaminants before and during batch production.
Clinical Trial Coordinator
Arkana Laboratories
12.2022 - 05.2023
- Prepared and documented internal requisition form for clinical trials, maintaining sample log in accordance with sample type, subject ID for each specific study in eLabJournal.
- Developing and maintaining Case Report Forms for each subject scored by pathologists in REDCAP Cloud for providing access to study sponsor and CROs.
- Collection, processing and shipment of clinical trial samples
- Ensure compliance with regulatory bodies such as the Food and Drug Administration FDA and Institutional Review Board IRB including preparing protocol amendments.
- Preparing Statement of Work for each sample based on study protocol for laboratory analysis.
Capstone Project Trainee
Microbiome Insights Inc
04.2022 - 07.2022
- Supported in development of Investigational Device Exemption by ensuring compliance with regulatory requirements.
- Researched FDAAA 801 guidelines and clinical trial registry databanks regulations in developing a pathway for study registration.
Associate Research Analyst (Regulatory Affairs)
Clarivate
03.2020 - 09.2020
- Updated Cortellis Clinical Trials clinical and regulatory Intelligence with latest pharmaceutical data filtered by key terms like actions and drug classes, inclusion/exclusion criteria.
- Conducted granular indexing of products for quick identification of competitor trials and make strategic decisions.
- Annotating the pharmaceutical patents based on active ingredient, mode of action among others.
- Compiled the latest country specific regulatory guidelines using Cortellis Regulatory Intelligence, which can be used by clients to make strategic regulatory decisions for the clinical studies and develop a timeline for their product regulatory approval.
- Compiled accurate clinical study data on Cortellis Clinical Trials Intelligence, which is used by clients to select reliable clinical site for their study.
Apprentice Trainee (Regulatory Affairs)
Viatris Inc (Mylan Laboratories)
01.2019 - 01.2020
- Collected, organized and conducted clinical data analysis of assigned clinical studies including identification, collection and reporting of adverse events in Form FDA 3500.
- Assisted in research planning and design including the development of standard operating procedures, protocol and Trial Master File TMF in accordance with FDA and ICH guidelines.
- Researched country specific regulatory guidelines set forth by the regulatory body and developing a regulatory pathway for registering the product in the market.
- Assisted in development of Statement of Investigator FORM FDA 1572 and Financial Disclosure Form FORM FDA 3455.
- Arranging internal project meetings, preparing and distributing meeting minutes to respective stakeholders.
Regulatory Affairs Intern
Sanzyme Biologics Private Limited
03.2018 - 05.2018
- Assisting the regulatory affairs team in ensuring compliance with relevant regulations and guidelines governing ANDA filings.
- Completing spreadsheets with metadata from current submission documents to ensure accurate document migration.
Education
Master of Science - Regulatory Affairs (Clinical Research)
Northeastern University
Boston, MA07.2022
Bachelor of Science - Pharmaceutical Sciences
Jawaharlal Nehru Technological University
Hyderabad, India08.2018
Skills
- Cortellis Regulatory Intelligence
- ELAB Journal (ELN)
- REDCap Cloud
- MS Word, SharePoint, Excel, Adobe
- Cortellis Clinical Trials Intelligence
- FORM FDA 1572, 3455
- Regulatory Research
- Good Clinical Practice
- Data collection and analysis
- Environmental monitoring
Certification
- Clinical Research Coordinator from CITI program
- Good Clinical Laboratory Practices (GCLP) from Royal College of Physicians of United Kingdom
- Good Clinical Practice (GCP) Certification from NIDA
Timeline
Contract Quality Control Analyst
Agenus Inc
11.2023 - 03.2024
Clinical Trial Coordinator
Arkana Laboratories
12.2022 - 05.2023
Capstone Project Trainee
Microbiome Insights Inc
04.2022 - 07.2022
Associate Research Analyst (Regulatory Affairs)
Clarivate
03.2020 - 09.2020
Apprentice Trainee (Regulatory Affairs)
Viatris Inc (Mylan Laboratories)
01.2019 - 01.2020
Regulatory Affairs Intern
Sanzyme Biologics Private Limited
03.2018 - 05.2018
Master of Science - Regulatory Affairs (Clinical Research)
Northeastern University
Bachelor of Science - Pharmaceutical Sciences
Jawaharlal Nehru Technological University
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