Shailesh Pawar

Member of Graduate Student Government at Northeastern University College of Professional Studies
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Location
Boston, Massachusetts, United States, US

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Credentials

  • Experiential Network
    Northeastern University
    Jul, 2023
    - Sep, 2024
  • Writing Case Studies
    LinkedIn
    Jul, 2023
    - Sep, 2024
  • RAPS Student Member
    Regulatory Affairs Certification Program
    Jun, 2023
    - Sep, 2024
  • FDA HUMAN DRUG REVIEW AND APPROVAL BASICS
    FDA
    Mar, 2023
    - Sep, 2024
  • Six Sigma Green Belt (CSSGB)
    Simplilearn
    Feb, 2023
    - Sep, 2024
  • Certified Specialty Pharmacist (CSP)
    Maharashtra State Pharmacy Council
    Aug, 2022
    - Sep, 2024
  • Publication selected by content selection committee(CSC)
    SCOPE DATABASE
    Aug, 2022
    - Sep, 2024
  • Communicating across cultures
    British Council
    Apr, 2022
    - Sep, 2024
  • Communication and Interpersonal skills at work
    University of Leeds
    Apr, 2022
    - Sep, 2024
  • Causality assessment of single case safety reports
    Uppsala Monitoring Centre
    Mar, 2022
    - Sep, 2024
  • Certificate course in Drug Regulatory Affairs
    Udemy
    Mar, 2022
    - Sep, 2024
  • GENERAL COURSE ON INTELLECTUAL PROPERTY RIGHTS
    World Intellectual Property Organization – WIPO
    Mar, 2022
    - Sep, 2024
  • Essentials of pharmacovigilance communications.
    Uppsala Monitoring Centre
    Feb, 2022
    - Sep, 2024

Experience

    • Member of Graduate Student Government
      • Dec 2022 - Present
    • United States
    • Higher Education
    • 700 & Above Employee
    • Student
      • Sep 2022 - Present

    • CASE STUDY WRITE-UP DRUG DEVELOPMENT BKK DRUG FOR NAUSEA AND INFLAMMATION
      • 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

    • Designed a fabricated Study protocol for Anastrozole [Team Leader]
      • 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.

    • India
    • E-Learning Providers
    • 1 - 100 Employee
    • Cultural Representative
      • 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

    • Event Coordinator
      • Aug 2018 - Jun 2022

      Led Sports and Dance Event Organization Successfully Anually

    • India
    • Hospitals and Health Care
    • 1 - 100 Employee
    • Hospital Pharmacist
      • May 2021 - Jul 2021

Education

  • Northeastern University
    Master's in Regulatory Affairs, Pharmaceutics and Drug Design
    2022 -
  • MMCOP Pune
    Bachelor of Pharmacy - BPharm, Pharmaceutical Sciences
    2018 - 2022
  • Rajarshi Shahu Mahavidyalaya (Autonomous), Latur
    HSC, Biology science
  • STNMS
    SSC, 9.0 CGPA

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