Summary
Overview
Work History
Education
Skills
Websites
WORK AUTHORIZATION
Publications
Timeline
Generic

Nivethitha Balakrishnan

REGULATORY AFFAIRS ASSOCIATE
Scarborough

Summary

Regulatory affairs professional with strong expertise in regulatory compliance, documentation, and submission processes. Known for effective collaboration with cross-functional teams and results-driven approach. Skilled in regulatory strategy, risk assessment, and ensuring adherence to industry standards. Adaptable and reliable, excelling in dynamic environments. Seeking opportunities to contribute to successful regulatory strategies in Medical Device, Biotech and Pharmaceutical industry.

Overview

7
7
years of professional experience
6
6
years of post-secondary education
2
2
Languages

Work History

PMS Analyst

HCL Technologies | Becton Dickinson
Madurai, Tamilnadu, India
02.2020 - 01.2025
  • Own and drive Complaint management process end to end for Medical Devices (Infusion Pump modules) by using Track wise tool.
  • Leveraged strong technical knowledge to provide technical expertise and assistance in handling complaints to comply with current FDA and Mandatory Medical Device Problem Reporting for Canada.
  • Evaluate incoming complaint information and maintain the record in the electronic database.
  • Perform follow up activities to obtain all the necessary details for Complaints.
  • Worked on multiple phases of compliance handling such as Complaint Remediation, Investigation, Decision Tree, MDR (Medical Device Reporting) and Quality for Medical Devices (Infusion Pump modules).
  • Experience in evaluation and determining the reportability of Complaints to USFDA and other regulatory bodies.
  • Writing investigation summaries based on technical product analysis information provided.
  • Manage and monitor medical device complaints, report on adverse events and malfunctions to FDA directly.
  • Ensuring record documentation and change control is maintained in up to date for audit readiness as per internal policies.
  • Applied problem-solving skills to achieve agreed results within time and with best quality, with proper communication, status updates, tracker & tool maintenance.
  • Worked on Enhanced Mass upload project to prepare data for bulk upload to USFDA and validation using Advanced Microsoft Excel features.
  • Involved in the HP ALM (Application life cycle management) validation activities.

Regulatory Affairs Associate

Softgel Healthcare
Chennai, Tamilnadu, India
07.2018 - 01.2020
  • Document management including uploading and tracking the submission documents according to established procedures and regulatory requirements.
  • Supported the compilation and maintenance of original ANDAs, NDA under the direction of manager for client and in-house filings to the FDA, TGA.
  • Demonstrated ability to collaborate with clients for the submission readiness and technical assistance.
  • Writing the controlled correspondence for requested information on a specific element of generic drug product development.
  • Provided regulatory support and guidance to cross-functional teams, leveraging a detail-oriented mindset to drive accurate and timely dossier submissions.
  • Reviewing various Chemistry Manufacturing Control (CMC) documents including the Product Development Report, Batch Records, Process Validation Records, Specifications, MOA, AMV, Stability Protocols, and Stability Data etc. for various pharmaceutical formulations.
  • Utilized strong analytical skills and Attention to Detail to ensure quality, accuracy, compliance and timely submission of documents.
  • Prepare product labels adhering to regulatory labeling requirements.
  • Referencing approved drug products Reference Listed Drug - RLD in ANDA submissions.

Education

Master of Pharmacy - Pharmaceutical Analysis

The Tamil Nadu Dr. M.G.R Medical University
Chennai, India
05.2016 - 05.2018

Bachelor of Pharmacy -

The Tamil Nadu Dr. M.G.R Medical University
Chennai, India
08.2011 - 08.2015

Skills

  • Dossier Authoring - CMC

  • CTD Regulatory Submissions

  • ICH- Quality guidelines

  • Knowledge of FDA, Health Canada regulations

  • Knowledge of Drug development, Product labeling, Standard operating procedures

  • Experience with electronic submissions

  • Experience using software platforms such as Fusion and TrackWise Tool

  • Good Documentation Practice (GDP)

  • Knowledge of 21 CFR 803 - MDR, 21 CFR 820 - Quality System regulations, ISO 13485:2016-MD QMS, ISO 14971 Risk Management, CAPA

  • Mandatory Medical Device Problem Reporting for Canada

  • Microsoft Office 365 (Advanced Excel, Word, PowerPoint), Adobe Acrobat, HPALM, SAP logon, DocuSign

  • Problem-solving, Excellent communication, Organizational skills

WORK AUTHORIZATION

Permanent Resident in Canada, authorized to work for any employer, Available to start immediately

Publications

  • Method development, validation and degradation studies of methocarbamol from methocarbamol injection by RP-HPLC method, International Journal of Pharmaceutical Sciences review and Research, 05/01/18
  • A diverse analytical approach for the estimation of Lornoxicam and Thiocolchicoside: A short review, International Journal of ChemTech Research, 11/01/18

Timeline

PMS Analyst

HCL Technologies | Becton Dickinson
02.2020 - 01.2025

Regulatory Affairs Associate

Softgel Healthcare
07.2018 - 01.2020

Master of Pharmacy - Pharmaceutical Analysis

The Tamil Nadu Dr. M.G.R Medical University
05.2016 - 05.2018

Bachelor of Pharmacy -

The Tamil Nadu Dr. M.G.R Medical University
08.2011 - 08.2015

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