Key Responsibilities:

• Understand requirements of regulatory submissions (IND, ANDA, NDA, DMF) in CTD/eCTD formats for various regulatory agencies (US-FDA, EMA, Health Canada).
• Assist with document-level publishing including bookmarking, hypertext linking, and preparing Tables of Contents.
• Provide Submission Publishing Support, archiving, and review of same-day dispatch, major/complex submissions.
• Ensure compliance with customer SOPs and policies as well as organizational procedures.

Desirable Skills and Experience:

• Experience in Publishing and Submissions is required.

Application Instructions: Interested candidates can apply by sending their resume to recruitment.india@navitaslifesciences.com.