Regulatory Affairs Intern
Core
Support the Regulatory Affairs team in preparing documentation, tracking submissions, and assisting with project coordination for pharmaceutical drug development.
Role type
Regulatory Affairs Intern
Builds
Regulatory submission documents (IND, CTA, briefing packages, nonclinical reports) and project timelines
Domain
Pharmaceuticals / Regulatory Affairs
Required skills
Regulatory documentation preparation, submission tracking, document review, project coordination, cross-functional communication, regulatory intelligence gathering, compliance monitoring
Preferred skills
Microsoft Office Suite, Adobe Acrobat, project management tools (Smartsheet, MS Project), clinical trials knowledge
Technologies
Smartsheet, MS Project, Microsoft Office Suite, Adobe Acrobat
Responsibilities
Organize and format regulatory submission documents, maintain submission trackers and document repositories, review documents for consistency and completeness, support creation of project timelines, coordinate with internal teams to gather documentation, conduct literature reviews and regulatory intelligence gathering, monitor changes in regulatory requirements
Seniority
Intern