Naglaxmi Kori
Dubai
Summary
Master of Science (M.Sc.) with over 9 years of experience in regulatory affairs and analytical method development. Proven track record in validation of injectable, reference standard characterization, and analytical research. Expertise in quality management systems (QMS), vendor management, and compliance with cGMP and GLP standards.
Overview
12
12
years of professional experience
1
1
Certification
Work History
Regulatory Affairs Officer
Arabian Ethical
07.2024 - Current
- Strong regulatory experience in Pharmaceutical, Conventional products, Herbal products, Veterinary products and Consumer products for UAE market and knowledge on submission for GCC region.
- Evaluation of price as per guidelines.
- Compliance checking, QC/ review of documents, QC/review of dossier.
- Preparation and manage new product submissions for regulatory approval to local Health Authority (HA) and lifecycle management.
- Liaise with Global regulatory colleagues to develop regulatory filing strategies for region.
- Liaise with local marketing and market access divisions to provide regulatory support. This includes formal quarterly regulatory feedback sessions.
- Reviewing documents in-line with regulatory requirements, specifications, analytical reports, process validation reports and stability data.
- Assist during Product Registration till approval and provide support to address MOH queries received for their other associated applicants.
- Ensure BE and stability study in accordance to Guidelines.
- Participating in project-specific meetings with client undertook project specific activities at high quality and in defined timelines according to SOPs.
- Manage around Registration of 15 Principle including Parma, Veterinary and Consumer.
- Coordinate with the commercial team to keep updated regarding the Regulatory compliance.
- Post approval reporting obligations and general product life cycle management support.
- Registration of products to get HAAD codes and DDC codes with authority.
- Registration for ESMA/MOIAT/ECAS products with Certification Companies.
QC Analyst
Acino Pharmaceutical
10.2023 - 06.2024
- Routine analysis of Finished products and stability samples.
- Analytical method transfer for Solid dosage and Injectables.
- Analysis of API, Raw material and excipient.
- Handling of Incident, deviation and change control.
- Trouble shooting of Instruments.
- Hands-on software like Lab solutions for Shimadzu system for HPLC, IR and UV spectrophotometer.
- Preparation of documents for inline with submission to local health authority.
QC Analyst
Microsynergy Pharmaceuticals
07.2022 - 09.2023
- Routine analysis of Finished products and stability samples.
- Chemical test for water sample analysis for chemical and Microbiology samples.
- Hands-on software like Lab solutions for Shimadzu system for HPLC, UV spectrophotometer
Sr. Executive Analytical R&D
Syngene International Ltd (Baxter)
10.2020 - 03.2021
- Currently working on Characterization, Evaluation, Validation of Reference standards.
- Preparation and review of Reference standard Protocols, Reports, and documents.
- Handling of LIMS activities for Reference standard qualification.
- Handling of Change control, Incident, Deviation and OOS.
- Preparation and review of Gap assessment reports.
- Hands-on software like Empower3 for HPLC.
Executive Analytical R&D
Micro Advance Research (R&D), Micro Labs Bangalore
11.2017 - 10.2020
- Currently working on Method development of Assay, Related substances.
- Protocol evaluation of Injectables and Inhalation solution. Diluent study and Compatibility Study for Injectables.
- Cleaning methods, analytical method Development and Validation.
- Handling of Regulatory queries.
- Reviewed response of queries and technical support in drafting response.
- Routine and stability analysis.
- Carrying out the product development & SPO preparation inline with the ICH guidelines.
- Handling quality notifications such as raising analytical incidents and deviations from investigation to disposal phase.
- Hands-on software like Empower3 for HPLC, Gas chromatography, LabSolutions for UV spectrophotometer, Particulate counter, Osmometer and Densitometer.
- Caliber LIMS version 3.2.1 for routine analysis and working standard qualification.
- Coordinating with Quality Assurance, and Regulatory Affairs to update Product development report.
- Having knowledge in Regulatory affairs for Europe submission and European variations.
Officer Quality Control
Bio plus life Sciences Private Limited
04.2014 - 11.2017
- Analysis of Regular & Process validation samples (Finished products)
- Preparations of Reagents and Volumetric solution
- Testing of drug products like Appearance, Average weight, Disintegration test, Friability test, Hardness test, pH meter.
- Preparation of Certificate of Analysis for finished product batch release.
- Handling software like EZ chrome for HPLC, UV Spectrophotometer-Cary 60 UV, Gas Chromatography.
Education
Master of Science - Biotechnology
PESIT College, Bangalore University
2012
Bachelor of Science - Biotechnology
RLS College, Belgaum, Dharwad University
09-2010
Skills
- Analytical skills
- Project Management
- Communication skills
- Teamwork
- Global regulatory compliance
- Regulatory submissions
- Verify eCTD
Certification
- Certification on Data integrity and Computer System Validation.
- Attended National Symposium in R L Science Institute, Belgaum.
- National Symposium on Olfaction and E-Nose.
Languages
English
Hindi
Marathi
Kannada
NOTABLE HIGHLIGHTS ACROSS TENURE
- Major contribution in getting the Registration done within the timeline.
- Completed the Gap assessment report within timeline.
- Preparation and review of Analytical method Validation Protocols and Reports
- Successfully completed Development and validation of ANDA projects within timeline.
- Completed Method Transfer of 2 projects to Quality control Lab in Plant.
Personal Information
Timeline
Regulatory Affairs Officer
Arabian Ethical
07.2024 - Current
QC Analyst
Acino Pharmaceutical
10.2023 - 06.2024
QC Analyst
Microsynergy Pharmaceuticals
07.2022 - 09.2023
Sr. Executive Analytical R&D
Syngene International Ltd (Baxter)
10.2020 - 03.2021
Executive Analytical R&D
Micro Advance Research (R&D), Micro Labs Bangalore
11.2017 - 10.2020
Officer Quality Control
Bio plus life Sciences Private Limited
04.2014 - 11.2017
Master of Science - Biotechnology
PESIT College, Bangalore University
Bachelor of Science - Biotechnology
RLS College, Belgaum, Dharwad University