Summary
Overview
Work History
Education
Skills
Accomplishments
Languages
Certification
Timeline
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Nabila Akhter

Toronto,Canada

Summary

Regulatory Affairs professional with a Post-Graduate Certificate in Pharmaceutical Regulatory Affairs & Quality Operations (President’s Honour List) and a Bachelor of Pharmacy. Skilled in regulatory submissions (NDS, SNDS, NC, Level III changes), post-approval activities, labeling and change control reviews, and maintaining compliance with Health Canada, FDA, and international guidelines. Certified in GCP-Canada and Health Canada Division 5, with strong expertise in GMP, documentation, and cross-functional collaboration.

Overview

8
8
years of professional experience
1
1
Certification

Work History

Taxpayer Service Agent (SP04)

Canada Revenue Agency
01.2024 - 05.2024
  • Reviewed submission documentation for accuracy and compliance with federal regulations.
  • Interpreted and applied policies, guidelines, and protocols to ensure compliance and consistency.
  • Prepared timely and accurate responses to clarification requests from individuals and businesses.
  • Maintained organized compliance records and documentation to support audits, reviews, and post-approval activities.
  • Researched policies and procedures to provide compliant solutions and resolve discrepancies.
  • Consistently ranked in the top 10% for quality assurance, documentation accuracy, and compliance.

Customer Care Specialist

Optima Communications Int. Inc. (Toronto Hydro)
01.2021 - 01.2024
  • Managing residential accounts for Toronto Hydro clients.
  • Consulting financial assistance programs, setting up payment arrangements, receiving payments, providing bill explanation & resolving billing inquiring and issues of clients.
  • Promoting and convincing clients to sign up for digital and self-service options offered by Toronto Hydro.
  • Responding to all inquiries, identifying issues & proposing solutions to client concerns.
  • Acting as a liaison between clients and Toronto Hydro.
  • Collaborating with remittance, technical & commercial team to align services & data management.
  • Preparing thorough reports on client details, concerns & proposed resolution.
  • Developing better KPI by improving call handling time, wrap-up time & first time solve scenarios.
  • Enhancing brand image by providing client service in a timely and efficient manner

Security Supervisor

Elite Condo Concierge
07.2018 - 01.2021
  • Supervised on-site teams and ensured adherence to safety protocols, emergency procedures, and incident reporting systems.
  • Led training programs and maintained compliance documentation for incident reporting and site audits.

Executive – Quality Assurance

ACI Pharmaceuticals Ltd.
01.2016 - 02.2018
  • Assisted with planning, compiling, reviewing, and coordinating regulatory dossiers (NDS, SNDS, NC, Level III changes) for Health Canada, FDA, DGDA, and WHO.
  • Supported responses to Health Canada and other authority queries during submission lifecycles.
  • Maintained drug product registrations and contributed to post-approval regulatory activities.
  • Reviewed product packaging, labeling, and promotional materials for compliance.
  • Evaluated change controls and supported implementation of regulatory updates.
  • Tracked submission milestones and post-approval commitments.
  • Collaborated with Quality, R&D, Supply Chain, and Production to support launches and lifecycle management.
  • Monitored regulatory guidance updates and ensured accurate, organized documentation.

Education

Post-Graduate Certificate - Pharmaceutical Regulatory Affairs & Quality Operations

Seneca Polytechnic
Toronto, ON
08-2025

Master's in Business - International Business

University of Dhaka
01.2017

Bachelor of Pharmacy - undefined

East West University
01.2015

Skills

  • Regulatory Submissions: NDS, SNDS, NC, Level III Changes; Responses to Health Canada queries
  • Regulatory Compliance: Health Canada, FDA, DGDA, WHO guidelines; GMP requirements
  • Post-Approval Activities: Product registration maintenance, lifecycle management, change control impact assessment
  • Labeling & Packaging: Review of product packaging, labeling, and promotional materials for compliance
  • Regulatory Documentation: Dossier compilation, audit readiness, organized record management
  • Quality Systems: Deviation/OOS investigations, CAPA, SOP management, risk assessment
  • Cross-Functional Collaboration: R&D, Quality, Supply Chain, Marketing, and Production teams
  • Technical Tools: Microsoft Office (Word, Excel, PowerPoint), Adobe Acrobat, TrackWise, EDMS, LMS
  • Certifications: Good Clinical Practice (GCP–Canada), Health Canada Division 5 – Clinical Trials

Accomplishments

  • Achieved President’s Honour Award in Pharmaceutical Regulatory Affairs & Quality Operations.

Languages

English
Full Professional

Certification

  • Good Clinical Practice (GCP) – Canada, CITI Program - 2025
  • Health Canada Division 5 – Drugs for Clinical Trials Involving Human Subjects, CITI Program - 2025

Timeline

Taxpayer Service Agent (SP04)

Canada Revenue Agency
01.2024 - 05.2024

Customer Care Specialist

Optima Communications Int. Inc. (Toronto Hydro)
01.2021 - 01.2024

Security Supervisor

Elite Condo Concierge
07.2018 - 01.2021

Executive – Quality Assurance

ACI Pharmaceuticals Ltd.
01.2016 - 02.2018

Master's in Business - International Business

University of Dhaka

Bachelor of Pharmacy - undefined

East West University

Post-Graduate Certificate - Pharmaceutical Regulatory Affairs & Quality Operations

Seneca Polytechnic
Nabila Akhter