Summary
Overview
Work History
Education
Skills
Certification
Languages Known
Publications
Hobbies and Interests
Timeline
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Rupal Singhal

Rupal Singhal

Jaipur,RJ

Summary

Positive, analytical, and solutions-oriented professional with strong foundation in regulatory compliance and quality assurance. Well-versed in understanding and interpreting regulatory guidelines, bringing valuable skills in document preparation and data analysis. Committed to ensuring seamless regulatory submissions and fostering compliant operational environment.

Overview

3
3
years of professional experience
1
1
Certification

Work History

Regulatory Affairs Associate

Triage Meditech Pvt Ltd
07.2022 - 10.2023
  • Reviewed regulatory submissions for compliance with FDA guidelines and industry standards.
  • Assisted in preparation of technical documentation for product approvals and registrations.
  • Conducted thorough evaluations of labeling and promotional materials for regulatory adherence.
  • Collaborated with cross-functional teams to ensure timely resolution of regulatory inquiries.

Regulatory Affair Associate (Trainee)

Qaaf Healthcare International
07.2021 - 01.2022
  • Absorbed knowledge of Legislative/Regulatory Affairs
  • Gained awareness of Drugs Regulatory Requirements i.e., Drugs & Cosmetics Act & Rules, NDCT Rules- 2019 & Medical Devices (MDR 2017 Rules), ICH GCP guidelines & CDSCO notifications
  • Assisted in application submission, maintenance and organization of regulatory files (electronic and paper) for proper tracking of information and archiving of regulated documents
  • Reviewed and evaluated technical and scientific data and reports required for file submission
  • Responded to queries on SUGAM portal raised by Regulatory/Health authorities (DCGI; CDSCO)
  • Served Post-approval change applications, endorsements of the products in existing Registration Certificate and Import License, reviewed Labels

Market Research Analyst (Expert Management Team)

GRG Health
10.2020 - 03.2021
  • Primary and Secondary Market Research: (Part of Expert panel):
  • Collected data and customized according to needs via multiple approaches to high Quality insights
  • Gathered Expert insights via gaining ground level knowledge ontarget players
  • Qualitative and Quantitative Research and fact-based recommendations
  • Prepared Transcripts

Education

MBA - Pharmaceutical Management

Jamia Hamdard
01.2020

B. Pharm - undefined

Amity University
01.2017

Skills

  • Interpersonal and Leadership Skills
  • Team worker & Player
  • Adaptable & Flexible
  • Submission preparation
  • Quality management systems
  • Document management
  • Regulatory submissions
  • Product labeling
  • Medical device regulations
  • Product information
  • Attention to detail
  • Critical thinking

Certification

  • Medical Devices Lead Auditor Training course-Quality Management System Training - [6/11/2023- 10/ 11/2023]
  • [Executive Programme in Clinical Research (RA + PV + CDM)],[MITCON BIO-PHARMA] - [09/03/2025 - 01/06/2025]

Languages Known

Hindi
English

Publications

  • Participated and presented a Review Article Titled "Honey: only as a delicious food or also as an antimicrobial agent as a co-author in the 6th Annual International Conference of Society of Pharmaceutical Education & Research (SPER), 2016
  • Participated and presented a Review Article on "Concept of sophisticated medication by pharmacist of digital era" as a co-author in the 30th Annual Conference of Indian Pharmacy Graduates Association, 2015

Hobbies and Interests

Reading and Gaining Knowledge, Interacting with people, Organizing, Learning Psychology

Timeline

Regulatory Affairs Associate

Triage Meditech Pvt Ltd
07.2022 - 10.2023

Regulatory Affair Associate (Trainee)

Qaaf Healthcare International
07.2021 - 01.2022

Market Research Analyst (Expert Management Team)

GRG Health
10.2020 - 03.2021

B. Pharm - undefined

Amity University

MBA - Pharmaceutical Management

Jamia Hamdard

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