Harini Keesara
Regulatory Affairs Specialist at Isto Biologics- Claim this Profile
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Bio
Credentials
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Master of Science
Northeastern UniversitySep, 2020- Nov, 2024 -
Experiential Network
Northeastern UniversityMay, 2020- Nov, 2024 -
1962USRx: Prescription Drug Regulation, Cost, and Access: Current Controversies in Context
Harvard UniversityMar, 2020- Nov, 2024 -
The FDA and Prescription Drugs: Drug Development and Approval
Harvard Medical SchoolJan, 2020- Nov, 2024 -
Experiential Network
Northeastern UniversityDec, 2019- Nov, 2024 -
Introduction to FDA Human Drug Review and Approval Basics
FDADec, 2019- Nov, 2024
Experience
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Isto Biologics
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United States
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Medical Equipment Manufacturing
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100 - 200 Employee
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Regulatory Affairs Specialist
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Oct 2022 - Present
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Regulatory Affairs Associate
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Aug 2021 - Sep 2022
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VERO Biotech
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United States
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Pharmaceutical Manufacturing
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100 - 200 Employee
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Regulatory Affairs Associate
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Oct 2020 - Aug 2021
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Neutron Therapeutics LLC
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United States
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Medical Equipment Manufacturing
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1 - 100 Employee
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Regulatory Strategy Intern - Capstone Project
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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.
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E Ink Corporation
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United States
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Appliances, Electrical, and Electronics Manufacturing
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400 - 500 Employee
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Regulatory Affairs Intern -Experiential Network
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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.
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Regulatory Affairs Intern (ICaSIO) - Experiential Network
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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
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Gleneagles Global Hospitals
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India
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Hospitals and Health Care
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700 & Above Employee
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Intern
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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
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Dr. Reddy's Laboratories
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India
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Pharmaceutical Manufacturing
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700 & Above Employee
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Clinical and Medical Operations Project Trainee
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Sep 2016 - Mar 2017
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Education
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Northeastern University
Master of Science - MS, Pharmacy Administration and Pharmacy Policy and Regulatory Affairs -
Shree Dattha Institute of Pharmacy, JNTU Hyderabad
Doctor of Pharmacy - PharmD -
Sri Chaitanya co-operative Education
Secondary School(11,12), Biology, Physics & Chemistry -
IEA International School
Primary School