Kruthika B
Bangalore
Summary
2 Years of working experience as Junior Regulatory Affairs Associate with expertise in Regulatory Information Management of core clinical trials.
Highly organized and dependable candidate skilled in managing multiple priorities and achieving team goals. Demonstrates a positive attitude and willingness to take on additional responsibilities.
Goal-oriented professional with strong communication skills and a comprehensive understanding of current regulatory standards.
Overview
2
2
years of professional experience
1
1
Certification
Work History
Junior Regulatory Affairs Associate
Parexel International Pvt Ltd
08.2022 - Current
- Professional experience in Regulatory Information Management System of tracking and archival of Clinical Trial Applications
- Basic knowledge on EU-CTR studies for ongoing clinical trial application in EU region
- Knowledge and hands on experience on Regulatory tools which includes Tracking and archival of global clinical trial application data and processes, it is essential that all information is accurate and kept up to date as per client requirements
- Create and update records in RIMS to ensure submission are documented properly including documentation of approval in Veeva RIM
- Experience in performing data entry in Calyx tool, PULSE & other client tools
- Experience in Veeva vault eTMF tool
- Archiving and Tracking of all kinds of documents like Submission activities including eCTD, NeeS (EU-CTR, DSUR, INDs), Approval and Labels (EU, LATAM, APAC) into client tools
- Accurate QC work on Calyx RIM and client-based tools
- Detect problems and propose appropriate solutions
- Accurate completion of tasks in Regulatory Information Management Systems (RIMS) for KPI generation in the context of data quality improvement and performance monitoring
- Guide, Support and Mentor junior colleagues
- Knowledge on Regulatory Guideline USFDA, EMA & ICH.
Education
M Pharm in Pharmaceutical Analysis -
Manipal College of Pharmaceutical Sciences
B Pharm -
PES College of Pharmacy
Skills
- Knowledge and basic understanding of CTIS Submission
- Professional Knowledge of ICH CTD Modules
Internship
Quality Analyst Intern in Cachet Pharmaceuticals Pvt Ltd (Alkem Groups), Baddi, HP
Learned to handle HPLC & various analytical instruments.
Project : Analytical Method Development and Validation of Gastrointestinal Drug by RP-HPLC.
Personal Information
- Date of Birth: 06/03/98
- Marital Status: Single
Disclaimer
I hereby declare that all the information mentioned above is true and up to the best of my knowledge and willing to provide the required documents when demanded.
Certification
- Clinical Trial Regulation 536/2014 and Clinical Trial Information System(CTIS) - New Regulatory Submission Pathway in the EU.
- Begin Planning your IND Submission.
Accomplishments
- Qualified Graduate Pharmacy Aptitude Test (GPAT) in 2020.
- Qualified National Institute of Pharmaceutical Education and Research (NIPER) entrance in 2020.
- Gold Medalist in RGUHS for Securing Distinction in the academic year 2018.
Languages
English
Hindi
Kannada
Tamil
Telugu
Timeline
Junior Regulatory Affairs Associate
Parexel International Pvt Ltd
08.2022 - Current
M Pharm in Pharmaceutical Analysis -
Manipal College of Pharmaceutical Sciences
B Pharm -
PES College of Pharmacy
- Clinical Trial Regulation 536/2014 and Clinical Trial Information System(CTIS) - New Regulatory Submission Pathway in the EU.
- Begin Planning your IND Submission.
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