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, ON08-2025
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