Profile Details

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USD 25 /hr

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Hire Kishor U.

India

USD 25 /hr

A pharmaceutical professional with hands on experience in regulatory writing for wide range of product portfolio.

Profile Summary

I have a Master's degree in pharmacology with about 7 years of experience in both CMC and the Clinical domains of regulatory affairs. I am well versed in the authoring, review, and finalization of regulatory modules in accordance with local/regional regulatory guidelines and format. I also have strong experience in compiling and publishing regulatory dossiers using eCTD tools.

Subject Matter Expertise

• ★ Medical Writing
• ☆ Regulatory Affairs
• ☆ Peer Review
• ☆ CMC Documentation
• ☆ Technical & Scientific Writing

Services

• Writing
• Research

Writing Clinical Trial Documentation, Technical Writing

Research Market Research, Fact Checking, Systematic Literature Review, Secondary Data Collection

Work Experience

Regulatory affairs consultant

Atnahs pharma UK limited

December 2019 - Present

Associate

Parexel International

March 2019 - February 2020

Education

Pharmacology

Bombay College of Pharmacy, Santa Cruz, Mumbai

July 2011 - October 2013

Certifications

• MS-CIT

  MKCL

  June 2008 - Present