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.
Strong organizational skills with the ability to manage multiple documents, tasks, and timelines simultaneously.
High attention to detail to ensure accuracy, completeness, and compliance of all regulatory documentation.
Experience in regulatory, IND, or related regulatory operations work.
Comfort working with electronic filing platforms and eDMS tools.
Ability to collaborate effectively with cross-functional internal stakeholders.
Strong written and verbal communication skills for clear documentation and stakeholder follow-up.