Gayatri Manogna Perumalla

Regulatory Affairs graduate (M.S., Northeastern University) with hands-on GMP/QA experience and applied coursework in ICH E6(R2), Health Canada, and FDA regulatory frameworks. Developed audit-ready SOPs and supported batch record documentation for a Health Canada/FDA-regulated manufacturer. Seeking an entry-level Regulatory Affairs Specialist role to support submissions, compliance documentation, and quality systems.

• Google Cloud
• Microsoft Excel
• Microsoft Word

1. Regulatory Affairs & QA Intern

   NATCO Pharma

   Dec 2021 to Dec 2022

   India

   • Maintained GMP-compliant documentation and batch records for a Health Canada/FDA-aligned production line, supporting audit readiness across ~50+ batch records • Reviewed and organized quality documentation against ICH and FDA compliance standards, flagging discrepancies before QA sign-off • Assisted in preparing materials for regulatory submission processes, gaining direct exposure to FDA and ICH filing requirements • Co-authored and revised SOPs as part of a process-improvement initiative, reducing documentation review turnaround • Partnered with QA, QC, and Production teams cross-functionally to close compliance gaps and support deviation resolution

2. Pharmacy Assistant

   Sri Lakshmi Medicals

   Nov 2019 to Jul 2020

   India

   • Processed 100+ prescriptions per week while maintaining full compliance with pharmacy regulatory standards • Maintained inventory and documentation records, ensuring accurate tracking for regulatory and audit purposes • Educated patients on medication usage, safety, and adherence, reinforcing regulatory and safety communication skills

1. Northeastern University

   Master of Science, Regulatory Affairs

   Toronto, ON

   2025

2. Vignan Pharmacy College

   Bachelor of Pharmacy, Pharmacy

   India

   2023

• Good Clinical Practice (GCP) – ICH E6(R2)

• Good Manufacturing Practices (GMP)

• NPTEL Certification – Cardiology

  NPTEL

• Patient Care Certification