CIPLA IS HIRING FOR REGULATORY AFFAIRS-NORTH AMERICA

CIPLA IS HIRING FOR REGULATORY AFFAIRS-NORTH AMERICA

Experience Required: 4 - 9 Years.

Location: Mumbai.

Job Description:

• - Preparation and review of PDF documents in accordance with FDA's guidance on PDF specifications.
• - Creation and review of TOC (table of content) and Bookmark.
• - To process and review the document for optical character recognition (OCR).
• - Naming of PDF documents as per guidance.
• - To do and review STF (study file tagging) in module 5.
• - Review of hypertext linked TOC and establishing external hypertext linking.
• - Managing activities with documentum software.
• - Ensure to have trial summary in the submission.

Creating submission plan and uploading of document under various module 1 to 5 in the eCTD software.  

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