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Dr. Shipra P. is a seasoned regulatory affairs professional with expertise in international drug regulatory affairs, project management, and clinical trial operations. She has worked with prominent companies like Ratnatris Pharmaceuticals and CBCC Global Research, and holds a Doctor of Philosophy degree in Drug Regulatory Affairs from Gujarat Technological University.

Experience

    • India
    • Pharmaceutical Manufacturing
    • 200 - 300 Employee
    • Assistant Manager-Project Management Specialist
      • Aug 2023 - Present

      As the Assistant Manager-Project Management Specialist I am providing support in the planning, execution, and monitoring of projects within the plant. This includes developing and maintaining project plans, schedules, and budgets; tracking project progress, and identifying and ensuring the successful delivery of projects within the plant. I am responsible for ensuring that projects are planned and executed effectively, that risks are identified and mitigated, and that stakeholders are kept informed of project status, and simultaneously providing training and support to project team members.This is a challenging and rewarding position that offers the opportunity to make a significant contribution to the industry.

    • Technical Officer-Plant International Regulatory Affairs
      • May 2021 - Aug 2023

      I am known for my technicality-specific knowledge of International Drug Regulatory Affairs in this organization.I have been looking after GCC, CIS, ASEAN, South African, and LatAm markets for their regulatory approvals here specifically for Oral Solid Dosage formulations and Small Volume Parenterals. However, my previous experiences in clearance and gate-pass of commercials are not helping just me but the organization as well, in extra.

    • Drug Regulatory Affairs Executive (ASEAN Market)
      • Jun 2019 - Apr 2021
      • Ahmedabad, Gujarat

      Regulatory Affairs for the Association of Southeast Asian Nations is entirely on the top of my tongue, whether for Drug Products’, Biologics, Nutraceuticals’ and Medical Devices dossier submission, or brand approval, from its filing to custom clearance or imports in ASEAN, because of work experience here.Moreover, my specialty was in exports here.

    • Internship Trainee
      • Dec 2018 - Jan 2019

      Establishing Clinical Trial Operations, ECG and Image Core laboratory, and Biorepository was the exact focus here.Clinical trial management in various indications including Cardiovascular, Oncology, and Medical Device Trials inclusive of CLASS-III was a bonus learning.

Education

  • 2019 - 2023
    Gujarat Technological University, Ahmedbabd
    Doctor of Philosophy - PhD, Drug Regulatory Affairs
  • 2017 - 2019
    Gujarat Technological University, Ahmedbabd
    Master's degree, Drug Regulatory Affairs
  • 2013 - 2017
    Gujarat Technological University, Ahmedbabd
    Bachelor's degree, Medicine

Suggested Services

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Industry Focus. “Pharmaceutical Manufacturing”

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