Vaishnavi Yeshirao

Regulatory Affairs | Mumbai

Professional Summary:

With 1.5 years of hands-on experience in clinical research with exposure to regulatory and ethical submissions. Knowledge of ICH-GCP, 21 CFR Part 11, and EU MDR regulations. Adept at preparing documentation for IRB/IEC, maintaining compliance, and supporting eCRF systems. Passionate about contributing to regulatory strategy and lifecycle management of drugs. Seeking a Regulatory Affairs Associate role to leverage clinical research experience in a quality- and compliance-driven environment.

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
• 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 life-cycle 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, ICH-GCP, 21 CFR Part 11, EU MDR, Clinical Trials, Castor EDC, Clinical Data Management, 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 into a Regulatory Affairs role where I can build a 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, effective, and approved drugs reach the end consumer. I 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
Thank you