Nivethitha Balakrishnan
Scarborough,ON
Summary
Regulatory Affairs & Quality Assurance Associate with 6+ years of experience in the pharmaceutical and medical device industries. Extensive experience in ANDA submissions for tablets and softgel capsules, including CMC authoring, eCTD preparation, and labeling review, achieving high regulatory acceptance. Skilled in medical device complaint management, including FDA Form 3500A and Health Canada MPR submissions, stability protocols, batch records, and analytical method validation. Proven ability to collaborate with cross-functional teams to ensure timely, compliant submissions and maintain audit-ready documentation across global markets.
Overview
7
7
years of professional experience
Work History
Senior Analyst
HCL Technologies
02.2020 - 01.2025
- Managed Product Quality Complaints end-to-end, overseeing customer complaints from system intake through investigation, regulatory reporting, and closure using TrackWise, in compliance with ISO 13485, GMP, and Health Canada regulations.
- Collaborated with the global complaints network and cross-functional teams to enhance complaint handling processes, system efficiency, and reporting quality.
- Evaluated complaints for reportability to Health Canada using risk-based decision trees and prepared Mandatory Problem Reports (MPRs) in accordance with the Canadian Medical Devices Regulations.
- Assessed and supported Foreign Mandatory Problem Reports (FMPRs) when applicable, ensuring accurate regulatory classification and documentation.
- Prepared and submitted US FDA Medical Device Reports (MDRs), including FDA Form 3500A, ensuring timely, complete, and compliant submissions.
- Conducted and documented complaint investigations, including technical product analysis, root cause determination, and preparation of clear investigation summaries.
- Communicated investigation outcomes to internal stakeholders and supported customer-facing responses as required.
- Liaised with Quality, R&D, Manufacturing, Marketing, and Field teams to ensure timely complaint resolution and alignment across functions.
- Supported and responded to Health Canada inquiries, providing accurate documentation and maintaining regulatory traceability.
- Managed the return and evaluation process for complaint samples, coordinating product assessments and replacement shipments to customers.
- Utilized metrics, trending, and reporting tools to monitor complaint performance, support investigations, and drive continuous improvement initiatives.
- Ensured non-conformances were properly documented, investigated, and addressed through root cause analysis and corrective actions to prevent recurrence.
- Maintained complaint handling documentation and procedures in a constant state of audit readiness, supporting internal and external audits and timely closure of audit actions.
- Contributed to an Enhanced Mass Upload project, preparing, validating, and quality-checking complaint datasets for bulk submission to the US FDA, leveraging advanced Microsoft Excel functions to ensure data integrity, regulatory compliance, and on-time delivery.
Regulatory Affairs Officer
Softgel Healthcare Private Limited
07.2018 - 01.2020
- Authored and compiled CMC sections for ANDA submissions, including tablets and softgel capsules, ensuring compliance with FDA, TGA, and global regulatory requirements.
- Managed regulatory document control activities, including uploading, tracking, and maintaining submission documents in accordance with SOPs, quality systems, and eCTD submission standards.
- Reviewed and authored comprehensive CMC documentation, including Product Development Reports, Master and Executed Batch Records, Process Validation documentation, Methods of Analysis (MOA), Analytical Method Validation (AMV), stability protocols, stability reports, and stability data across multiple dosage forms.
- Drafted controlled regulatory correspondence in response to agency requests, addressing specific generic drug product development elements.
- Ensured technical accuracy, data consistency, and regulatory compliance of CMC sections prior to submission, supporting first-cycle approval readiness.
- Prepared and reviewed product labeling and artwork, ensuring alignment with regulatory labeling requirements, approved RLD references, and submission dossiers.
- Maintained regulatory documentation and submission modules in a constant state of inspection and audit readiness, supporting internal reviews and regulatory inspections.
- Supported cross-functional teams in CMC data review and validation, ensuring completeness and regulatory compliance for tablets and softgel capsules
Education
Post-Graduate Diploma - Quality Assurance And Regulatory Affairs
Academy of Applied Pharmaceutical Sciences
Toronto, ON08-2026
Master of Pharmacy - Pharmaceutical Analysis
The Tamil Nadu Dr. M.G.R. Medical University
India05-2018
Bachelor of Pharmacy - Pharmaceutical Sciences
The Tamil Nadu Dr. M.G.R. Medical University
India08-2015
Skills
Quality Assurance & Complaint Management: Product Quality Complaints, FDA Form 3500A, Health Canada MPR/FMPR, TrackWise, Root Cause Analysis, CAPA, Audit Readiness, GMP/ISO 13485 Compliance
Regulatory Affairs & CMC: ANDA/NDA Submissions (Tablets & Softgels), CMC Authoring & Review, eCTD, Stability Protocols & Reports, Batch Records, Process Validation, MOA & AMV, Product Development Reports, Labeling & Artwork Review
Technical Tools & Systems: eCTD Document Management, HP ALM, Advanced Excel (Data Validation, Reporting, Analysis)
Languages
English
Professional Working
Timeline
Senior Analyst
HCL Technologies
02.2020 - 01.2025
Regulatory Affairs Officer
Softgel Healthcare Private Limited
07.2018 - 01.2020
Post-Graduate Diploma - Quality Assurance And Regulatory Affairs
Academy of Applied Pharmaceutical Sciences
Master of Pharmacy - Pharmaceutical Analysis
The Tamil Nadu Dr. M.G.R. Medical University
Bachelor of Pharmacy - Pharmaceutical Sciences
The Tamil Nadu Dr. M.G.R. Medical University