Santosh Tripathy Regulatory Affairs, eCTD, Associate Manager
No reviews yet

I have work experience as a Drug regulatory affairs professional and also as regulatory affairs tutor.

For me teaching is a passion. I have online as well as offline teaching experience in various subjects in Pharmacy and specialized in Drug regulatory affairs. Also I taught school and college students and helped them clearing their doubts.

My way of teaching is not just completing the course/syllabus but explain the fundamentals and detect the route cause for a student weakness, so that I can work on that and improve it. I can take responsibility on full course of a subject or multiple subjects and can also help in an assignment.

I have more than 10 years of industrial experience in Drug Regulatory Affairs. I have experience on review of clinical study reports, protocols, IBs and other clinical documents. I have hands on experience in clinical study monitoring and audit of clinical facilities. I have handled various global markets like EU, US, UK, Asia Pacific, Gulf Corporation Counsil. I have done regulatory publishing in various formats like eCTD, NeeS and Paper. I have handled various softwares used i.e eCTD publishing software, Validation software, Document Management system software.

Subjects

  • Biology Pre-KG, Nursery-Masters/Postgraduate

  • Science Pre-KG, Nursery-Grade 10

  • Zoology Pre-KG, Nursery-Masters/Postgraduate

  • Mathematics Pre-KG, Nursery-Grade 4

  • Pharmaceutics Beginner-Intermediate

  • Drug Regulatory Affairs Beginner-Expert

  • Pharmacognosy Beginner-Expert

  • Pharmacology and Pathology Beginner-Expert

  • Pharmaceutical & Medicinal Chemistry Beginner-Intermediate

  • Pharmaceutical Biochemistry Beginner-Intermediate

  • Pharmaceutical Regulatory Affairs Beginner-Expert

  • Pharma Jurisprudence Beginner-Expert

Experience

  • Associate Manager, Regulatory Submission (Jan, 2021–Present) at Fortrea, Inc. New Jersey
    Regulatory Publishing, Prepare submission package and submission to regulatory authorities like EMA, Spain, UK etc
  • Sr. Publisher, Regulatory Submission (Feb, 2017–Dec, 2020) at Navitas Life Sciences, Chennai
    Regulatory Publishing in various formats like eCTD, NeeS, Paper and submission to various regulatory authorities like USFDA, EMA, etc.
  • Sr. Clinical Research Associate (Nov, 2012–Jan, 2017) at Micro Labs, Bangalore
    Review Clinical study reports, prepare and compile dossier, eCTD publishing, Clinical study monitoring, Facility and study audit

Education

  • Master in Pharmaceutical Technology (Jun, 2010–Jun, 2012) from Bijupatnaik University of Technology–scored 90%

Fee details

    ₹500–1,500/hour (US$5.90–17.69/hour)

    Vary depending on the helping in assignment or homework

Reviews

No reviews yet. Be the first one to review this tutor.