Regulatory Operations Associate

Job Summary

Focusing on regulatory operations, the contract Regulatory Operations Associate will compile and submit documents to the FDA using eCTD software while working remotely until the end of the year.

Key responsibilities

• Compile, publish, and submit regulatory documents (sNDA) to the FDA using eCTD software, ensuring compliance with all technical and formatting requirements
• Build and manage electronic submission packages using the eCTD backbone structure and submit via the ESG portal
• Independently manage submission activities with minimal oversight

Required qualifications

• 3+ years of hands-on Regulatory Operations experience focused on eCTD publishing and FDA submission support
• Proficiency with eCTD publishing tools such as Omnicia, Lorenz, or Extedo
• Demonstrated ability to build eCTD backbone structures and compile submission-ready packages
• Proven track record of completing and submitting FDA regulatory submissions independently
• Experience with New Drug Application (NDA) and Electronic Common Technical Document (eCTD)