Shailesh Pawar
Member of Graduate Student Government at Northeastern University College of Professional Studies- Claim this Profile
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Credentials
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Experiential Network
Northeastern UniversityJul, 2023- Sep, 2024 -
Writing Case Studies
LinkedInJul, 2023- Sep, 2024 -
RAPS Student Member
Regulatory Affairs Certification ProgramJun, 2023- Sep, 2024 -
FDA HUMAN DRUG REVIEW AND APPROVAL BASICS
FDAMar, 2023- Sep, 2024 -
Six Sigma Green Belt (CSSGB)
SimplilearnFeb, 2023- Sep, 2024 -
Certified Specialty Pharmacist (CSP)
Maharashtra State Pharmacy CouncilAug, 2022- Sep, 2024 -
Publication selected by content selection committee(CSC)
SCOPE DATABASEAug, 2022- Sep, 2024 -
Communicating across cultures
British CouncilApr, 2022- Sep, 2024 -
Communication and Interpersonal skills at work
University of LeedsApr, 2022- Sep, 2024 -
Causality assessment of single case safety reports
Uppsala Monitoring CentreMar, 2022- Sep, 2024 -
Certificate course in Drug Regulatory Affairs
UdemyMar, 2022- Sep, 2024 -
GENERAL COURSE ON INTELLECTUAL PROPERTY RIGHTS
World Intellectual Property Organization – WIPOMar, 2022- Sep, 2024 -
Essentials of pharmacovigilance communications.
Uppsala Monitoring CentreFeb, 2022- Sep, 2024
Experience
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Member of Graduate Student Government
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Dec 2022 - Present
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Northeastern University
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United States
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Higher Education
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700 & Above Employee
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Student
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Sep 2022 - Present
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CASE STUDY WRITE-UP DRUG DEVELOPMENT BKK DRUG FOR NAUSEA AND INFLAMMATION
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Sep 2022 - Present
I developed regulatory strategies aimed at facilitating the product development of the BKK drug, a locally administered anti-inflammatory pain medication that combines three FDA-approved drugs - bupivacaine, ketorolac, and ketamine. In this capacity, I ensured the creation of labeling in compliance with the 21 CFR part 201.5 labeling regulations established by the US Food and Drug Administration (FDA).To anticipate potential risks associated with non-clinical testing, I leveraged my extensive knowledge of ICH guidelines, including S1A, S2, S3A, and S12. This helped to identify and mitigate potential risks, ensuring that the product development process proceeded smoothly and efficiently. Show less
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Designed a fabricated Study protocol for Anastrozole [Team Leader]
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Jan 2023 - Feb 2023
• Drafted a template and provided details on eight required elements of informed consent as a lead for a group project.•Study to evaluate the efficacy and safety of different durations of anastrozole therapy after 2-3 years of Tamoxifen as adjuvant therapy in postmenopausal women with breast cancer.
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Savitribai Phule Pune University
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India
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E-Learning Providers
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1 - 100 Employee
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Cultural Representative
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Aug 2020 - Jun 2022
Led a team of 14 committee members in organizing a highly successful multicultural festival, attracting over 500 attendees and showcasing diverse traditions, cuisines, and performances, Active Member of Anti-Ragging Committee
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Event Coordinator
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Aug 2018 - Jun 2022
Led Sports and Dance Event Organization Successfully Anually
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Muktai Hospital
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India
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Hospitals and Health Care
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1 - 100 Employee
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Hospital Pharmacist
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May 2021 - Jul 2021
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Education
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Northeastern University
Master's in Regulatory Affairs, Pharmaceutics and Drug Design -
MMCOP Pune
Bachelor of Pharmacy - BPharm, Pharmaceutical Sciences -
Rajarshi Shahu Mahavidyalaya (Autonomous), Latur
HSC, Biology science -
STNMS
SSC, 9.0 CGPA