2–5+ years of experience in Regulatory Affairs Operations, Regulatory Document Management, or Regulatory Publishing support.
Hands-on experience supporting IND filings within a pharmaceutical, biotech, or drug discovery environment.
Familiarity with Module 2 documentation and its components in the context of regulatory submissions.
Experience with document tracking, document routing, and version control processes in a regulated environment.
Knowledge of eCTD structure and regulatory filing requirements for IND submissions.
Proficiency with electronic document management systems such as Veeva, MasterControl, SharePoint, or similar platforms.
Reliable workspace
Consistent internet access