Summary
Overview
Work History
Education
Skills
Relevant Healthcare Experience
Timeline
Generic

Prakruti Patel

North York,Canada

Summary

Dynamic Regulatory Affairs professional with hands-on experience at VEER PHARMACHEM, excelling in submission preparation and document control. Proven ability to enhance compliance and quality through meticulous attention to detail and collaborative teamwork. Skilled in eCTD formatting and regulatory adherence, ensuring timely and accurate submissions that meet FDA/EMA standards.

Overview

1
1
year of professional experience

Work History

Regulatory Affairs & Compliance Associate

VEER PHARMACHEM
, India
05.2022 - 01.2023
  • Ensured submission-ready regulatory dossiers for national and global filings.
  • Assisted in preparing electronic submission packages with eCTD/CTD-aligned content and organized Module 2 summaries for regulatory review.
  • Enhanced document completeness and alignment with FDA/EMA expectations for electronic submissions.
  • Maintained regulatory consistency and document formatting across multiple files to ensure clear submission readiness.
  • Executed detailed formatting in Microsoft Word and Adobe Acrobat to standardize templates and pagination for regulatory submissions.
  • Minimized formatting discrepancies to enhance reviewer navigation and facilitate efficient document review.
  • Prevented submission delays by validating hyperlinks and conducting cross-reference checks of eCTD folder structure.
  • Identified and corrected broken links and structural issues before submission readiness checks.

Pharmacist

Lifeline Pharmacy
, India
09.2021 - 04.2022

Dispensed medications accurately according to patient prescriptions.

  • Administered immunizations and vaccinations in compliance with established protocols.
  • Detected and reported therapeutic incompatibilities for patient safety.
  • Analyzed prescription trends to enhance pharmacy services and improve patient care outcomes.
  • Supervised staff, driving top performance towards pharmacy objectives.
  • Maintained audit-ready records and version histories in document management systems to support regulatory compliance.
  • Prepared and formatted regulatory documents using Microsoft Word and Adobe Acrobat to ensure compliance.
  • Reviewed submission materials for adherence to local authority standards and FDA/EMA guidance.

Education

Regulatory Affairs And Quality Operations - Pharmacy

Fansahwe College
Toronto, ON
08.2025

Bachelor of Pharmacy - Pharmacy

Dhanvantri Pharmacy College
Kim, India
09.2022

Skills

  • Regulatory adherence
  • Document control
  • Quality control measures
  • Submission preparation skills
  • Detail orientation
  • Data integrity
  • Collaborative teamwork
  • Project oversight
  • Monitoring compliance
  • Audit assistance
  • Reviewing documentation
  • Policy evaluation
  • Analytical skills
  • Product recall procedures
  • Internal audits
  • Standard operating procedure writing
  • Food safety education programs
  • Quality assurance processes
  • Hazard assessment

Relevant Healthcare Experience

Nutritionist | Healthy Planet | September 2025-Present

.

  • Provided evidence-based nutrition guidance and product recommendations compliant with Health Canada regulations.
  • Reviewed supplement labels and health claims for regulatory compliance and risk mitigation.
  • Maintained accurate client records and monitored supplement–medication interactions.
  • Developed educational materials and trained staff on nutrition and compliance standards.

.

Pharmacy assistant Co-op | Humber Summit Pharmacy | May 2025- August 2025

.

  • Supported prescription processing and medication dispensing in compliance with provincial pharmacy regulations and patient safety standards.
  • Performed data entry, documentation, and record maintenance ensuring accuracy and confidentiality (PHIPA compliance).
  • Assisted pharmacists with medication reconciliation, inventory management, and quality control procedures.
  • Reviewed prescriptions for completeness and escalated discrepancies to ensure regulatory compliance and risk mitigation.

Timeline

Regulatory Affairs & Compliance Associate

VEER PHARMACHEM
05.2022 - 01.2023

Pharmacist

Lifeline Pharmacy
09.2021 - 04.2022

Regulatory Affairs And Quality Operations - Pharmacy

Fansahwe College

Bachelor of Pharmacy - Pharmacy

Dhanvantri Pharmacy College

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Prakruti Patel