Vaishnavi Yeshirao – Unlocking Success in Clinical Research with Regulatory Expertise

Professional Summary

Vaishnavi Yeshirao is a dedicated professional with 1.5 years of hands-on experience in clinical research, focusing on regulatory and ethical submissions. She is well-versed in ICH-GCP, 21 CFR Part 11, and EU MDR regulations. Vaishnavi excels in preparing documentation for IRB/IEC, ensuring compliance, and supporting eCRF systems. She is passionate about contributing to regulatory strategy and drug lifecycle management.

Core Competencies

• Regulatory Knowledge: FDA Guidelines, EU Guidelines, Regulatory Submissions, Good Clinical Practice (GCP), ICH Guidelines, Clinical Trials
• Clinical Data Management Systems (Castor EDC)
• Clinical Trial Lifecycle Support
• DMP
• On-site Monitoring
• 21 CFR

Technical Skills

• Power BI
• R coding
• LaTEX
• Excel

Certifications

• Regulatory Affairs – Basics of Global Regulatory Systems
• Mini-Course: EU Medical Device Regulation (EU MDR)
• Good Clinical Practice (NIDA)
• Principles and Practice of Clinical Research (NIH)
• Clinical Data Management (Biotecnika)

Professional Experience

Project Technical Support III (Ad-hoc) – ICMR
LTMMC, Mumbai | Mar 2023 – Sep 2024

• CTM
• eCRFs
• Data Accuracy and Management

Key Achievements:

• Enrollment Management success
• Managed 100+ patient enrollments with 90% follow-up compliance
• IRB submissions
• Contributed to ethical submissions with IEC and project
• Communication with sponsor
• Organization and quality control
• Oversaw end-to-end lifecycle of the trial independently

Education

M.Sc. Microbiology
HBSU, Mumbai | 2020 – 2022

B.Sc. Microbiology
University of Mumbai | 2017 – 2020

Languages

English, Hindi, Marathi

Skills

Regulatory Affairs, Clinical Research, ICH-GCP, Drug Lifecycle Management, Regulatory Strategy, FDA Guidelines, EU Guidelines, Clinical Data Management, Good Clinical Practice, Clinical Trials, Power BI, R coding, LaTEX, Excel

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Cover Letter:

Vaishnavi Yeshirao
Regulatory Affairs
Hi HR team
I am experienced in Clinical Research in Mumbai location and looking to transition in Regulatory Affairs role where I can build foundation on my basic regulatory knowledge of US FDA, EMA, PDMA , NMPA, etc and different regulatory pathways. I am enthusiastic to work in this field and ensure that only safe and effective and approved drugs reach the end consumer. I would would appreciate the opportunity to work with Sharda Chem and start my career in Regulatory Affairs with you
Let me know if you have any questions
Thankyou