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
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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.