Summary
Overview
Work History
Education
Skills
Certification
Projects
Timeline
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Krishna Patel

Boston,MA

Summary

Adept at managing regulatory documents from start to finish, including assessing audits, evaluating technical data and checking information accuracy. Well-spoken and friendly with top-notch abilities in information verification, report preparation and records management.

Overview

1
1
Certification

Work History

Intern

Sun Pharmaceutical Industries
Halol, India, Gujarat
07.2022 - 08.2022
  • Assisted in the preparation of regulatory submissions for FDA and other international agencies.
  • Compiled, reviewed, and edited technical documents to ensure accuracy and compliance with applicable regulations.
  • Participated in cross-functional teams to develop strategies for obtaining approval of products in different countries or regions.
  • Collaborated with internal departments such as Quality Assurance, Research and Development, Legal, Clinical Affairs, Regulatory Compliance and Marketing Communications teams on various projects related to regulatory affairs processes.
  • Coordinated activities related to document control procedures within the organization.

Education

Master of Science - Regulatory Affairs

Northeastern University
Boston, MA
05-2025

Bachelor of Pharmacy -

Pioneer Pharmacy College
India
07-2023

Skills

  • Teamwork And Collaboration
  • Documentation Management
  • Regulatory Compliance
  • Compliance Testing
  • Documentation Support
  • Reporting And Documentation
  • Filing And Data Archiving
  • Standards Review
  • Database Management
  • Written Communication Skills
  • Team Support
  • Strategic Planning And Analysis
  • Problem-Solving
  • Analyzing Data

Certification

  • Presented paper at International Conference on “Machine Vision and Augmented Intelligence (MAI2021)
  • Attended 8 weeks of, the Industry Connect Internship Program (Jan 2022 to Mar 2022)
  • Attended training at the hands of an Application specialist from the Anchrom TLC/HPTLC Department (Nov 2022)
  • RAPS Membership- Regulatory Affairs Professionals Society (March 2024- March 2025)

Projects

  • Diabetes Prediction Using Deep Learning Model (Jan 2021) : Presented a fully automatic diabetes detection system. The proposed detection system included the pre-processing of features, training, and testing stages. The highest 96.01% of training and 96.06% of testing accuracy are obtained with the proposed model.
  • Method Development And Validation of Dapagliflozin and Vildagliptin in their Combined Pharmaceutical Dosage Form by High-Performance Thin Layer Chromatography (Jul 2023): As per ICH guidelines, the developed method had its linearity, accuracy, precision, limit of detection, limit of quantification, and assay within accepted criteria.

Timeline

Intern

Sun Pharmaceutical Industries
07.2022 - 08.2022

Master of Science - Regulatory Affairs

Northeastern University

Bachelor of Pharmacy -

Pioneer Pharmacy College
Krishna Patel