Harini Keesara

Regulatory Affairs Specialist at Isto Biologics
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Contact Information
us****@****om
(386) 825-5501
Location
Boston, Massachusetts, United States, US

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Credentials

  • Master of Science
    Northeastern University
    Sep, 2020
    - Nov, 2024
  • Experiential Network
    Northeastern University
    May, 2020
    - Nov, 2024
  • 1962USRx: Prescription Drug Regulation, Cost, and Access: Current Controversies in Context
    Harvard University
    Mar, 2020
    - Nov, 2024
  • The FDA and Prescription Drugs: Drug Development and Approval
    Harvard Medical School
    Jan, 2020
    - Nov, 2024
  • Experiential Network
    Northeastern University
    Dec, 2019
    - Nov, 2024
  • Introduction to FDA Human Drug Review and Approval Basics
    FDA
    Dec, 2019
    - Nov, 2024

Experience

    • United States
    • Medical Equipment Manufacturing
    • 100 - 200 Employee
    • Regulatory Affairs Specialist
      • Oct 2022 - Present

    • Regulatory Affairs Associate
      • Aug 2021 - Sep 2022

    • United States
    • Pharmaceutical Manufacturing
    • 100 - 200 Employee
    • Regulatory Affairs Associate
      • Oct 2020 - Aug 2021

    • United States
    • Medical Equipment Manufacturing
    • 1 - 100 Employee
    • Regulatory Strategy Intern - Capstone Project
      • Apr 2020 - Oct 2020

      Cancer Device Regulatory requirements In South Korean Jurisdiction. Responsibilities: • Advised our project sponsor in determining the therapeutic classification of the product according to South Korean • Reported various regulatory requisites and marketing approval procedures in South Korean Jurisdiction • Provided them with possible regulatory strategies for streamlining communication and promote efficiency. Cancer Device Regulatory requirements In South Korean Jurisdiction. Responsibilities: • Advised our project sponsor in determining the therapeutic classification of the product according to South Korean • Reported various regulatory requisites and marketing approval procedures in South Korean Jurisdiction • Provided them with possible regulatory strategies for streamlining communication and promote efficiency.

    • United States
    • Appliances, Electrical, and Electronics Manufacturing
    • 400 - 500 Employee
    • Regulatory Affairs Intern -Experiential Network
      • Jan 2020 - Mar 2020

      HIPAA (Health Insurance Portability and Accountability Act) Requirements Responsibilities: • Assisted our project sponsor with HIPAA requirement on Patient e-Paper Information Display Devices • Provided HIPAA compliance requirements for information/data transfer from electronic health/medical records (EMR/EHR)to Mobile devices, ePaper communication board and ePaper door sign thereby improving PHI (Protected Health Information), privacy and confidentiality of patient data. HIPAA (Health Insurance Portability and Accountability Act) Requirements Responsibilities: • Assisted our project sponsor with HIPAA requirement on Patient e-Paper Information Display Devices • Provided HIPAA compliance requirements for information/data transfer from electronic health/medical records (EMR/EHR)to Mobile devices, ePaper communication board and ePaper door sign thereby improving PHI (Protected Health Information), privacy and confidentiality of patient data.

    • Regulatory Affairs Intern (ICaSIO) - Experiential Network
      • Oct 2019 - Dec 2019

      Cannabis Regulations Research- Cannabis Industry Responsibilities: • Executed a project with Toronto based sponsor on current regulatory situation globally (with a focus on Canada and US) with a mission to advocate for policies and laws that support a vibrant and balanced industry • Compiled data on Regulatory Framework of Cannabis in Canada and California • Scrutinised effects of Cannabis on Pharmaceutical, Food, Agricultural industries and provided recommendations for improving Cannabis oversight Show less

    • India
    • Hospitals and Health Care
    • 700 & Above Employee
    • Intern
      • Jun 2017 - Jun 2018

      Responsibilities: • Engaged in ward round trainings(with a focus in Medical, Cardiology, Nephrology and Surgery Departments) and Collaborated with physicians on providing patient counselling recommendations • Monitored for drug interactions which enhanced my knowledge on Pharmacovigilance • Provided cost-effective alternative pharmacotherapies which fostered patient health care Responsibilities: • Engaged in ward round trainings(with a focus in Medical, Cardiology, Nephrology and Surgery Departments) and Collaborated with physicians on providing patient counselling recommendations • Monitored for drug interactions which enhanced my knowledge on Pharmacovigilance • Provided cost-effective alternative pharmacotherapies which fostered patient health care

    • India
    • Pharmaceutical Manufacturing
    • 700 & Above Employee
    • Clinical and Medical Operations Project Trainee
      • Sep 2016 - Mar 2017

Education

  • Northeastern University
    Master of Science - MS, Pharmacy Administration and Pharmacy Policy and Regulatory Affairs
    2018 - 2020
  • Shree Dattha Institute of Pharmacy, JNTU Hyderabad
    Doctor of Pharmacy - PharmD
    2012 - 2018
  • Sri Chaitanya co-operative Education
    Secondary School(11,12), Biology, Physics & Chemistry
    2010 - 2012
  • IEA International School
    Primary School
    2007 - 2010

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