プロフィール詳細

プロジェクトを作成

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Kishor U.に依頼

India

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

プロフィール概要

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.

専門分野

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

サービス

• Writing
• Research

Writing Clinical Trial Documentation, Technical Writing

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

職務経験

Regulatory affairs consultant

Atnahs pharma UK limited

12月 2019 - 現在

Associate

Parexel International

3月 2019 - 2月 2020

学歴

Pharmacology

Bombay College of Pharmacy, Santa Cruz, Mumbai

7月 2011 - 10月 2013

認定資格

• MS-CIT

  MKCL

  6月 2008 - 現在