Summary
Overview
Work History
Education
Skills
Interests
Publications
Timeline
Hi, I’m

KAUSTAV MAHAPATRA

Regulatory CMC Strategist
Chennai,TN
KAUSTAV  MAHAPATRA

Summary

Experienced regulatory affairs professional with 1.7 years of expertise in dossier submissions and post-approval change management across diverse markets, including the US, EU, Canada, ANZ, APAC, LATAM, and AFME regions. Seeking a challenging opportunity for growth. Possesses strong decision-making skills and adaptability, fostering excellent collaboration within internal teams. Takes a proactive approach and initiative in achieving organizational goals.

Overview

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

Work History

Pfizer

Associate CMC Author & Strategist-1
07.2023 - Current

Job overview

  • Providing regulatory review, global regulatory impact assessment of change proposals and identification of required documentation for global submissions
  • Responsible for preparation and review of high quality CMC documentation for HA submission in US, EU, Canada, ANZ, LATAM, APAC, AFME markets by applying agreed global regulatory strategies assuring regulatory compliance within agreed timelines
  • Preparation of responses to HA queries during product lifecycle
  • Provide regulatory support for quality events and review of plant documents such as specifications, manufacturing documents, stability data and other technical documents
  • Managed post-approval changes, ensuring all necessary documentation was submitted accurately and on time.
  • Played an instrumental role in obtaining approval for multiple products by effectively managing filing timelines and deliverables.
  • Enhanced regulatory compliance by meticulously reviewing and editing submission documents.
  • Assisted with regulatory product compliance initiatives such as GPC alignment, RPS.
  • Monitored industry trends and regulatory updates, maintaining a strong understanding of current best practices in the field.

Radiant Research Services Pvt Ltd

Research Intern
10.2022 - 04.2023

Job overview

  • Performing in-vitro cytotoxicity studies in cell cultures using MTT
  • Performing immunoassay using ELISA, gene expression studies
  • Completed research, compiled data, and assisted in timely reporting.
  • Conducted literature reviews to identify relevant research articles and support project objectives.

Education

JSS COLLEGE OF PHARMACY

Master of Pharmacy from Pharmaceutical Biotechnology
01.2021 - 04.2023

University Overview

GPA: 9.35 / 10

DAYANANDA SAGAR UNIVERSITY

Bachelor of Pharmacy
01.2017 - 04.2021

University Overview

GPA: 8.47 / 10

Skills

ICH Guidelines

Interests

Project management, Power BI, AI and ML

Publications

Publications

Research article on the topic " Comparative study of anti inflammatory and anthelmintic activity of Trema orientalis linn on WJPPS journal.

Research article In-vitro anti ageing and anti oxidant evaluation through Collagen , Elasten, MMP-1 , MMP-9 gene expression.

Timeline

Associate CMC Author & Strategist-1
Pfizer
07.2023 - Current
Research Intern
Radiant Research Services Pvt Ltd
10.2022 - 04.2023
JSS COLLEGE OF PHARMACY
Master of Pharmacy from Pharmaceutical Biotechnology
01.2021 - 04.2023
DAYANANDA SAGAR UNIVERSITY
Bachelor of Pharmacy
01.2017 - 04.2021
KAUSTAV MAHAPATRARegulatory CMC Strategist