Regulatory Affairs Intern

Job Description

POSITION SUMMARY:
We are seeking a motivated and detail-oriented Regulatory Affairs Intern to provide day-to-day support for Regulatory Affairs activities and operations.

Under the guidance of Regulatory Affairs team members, this role will assist with document organization, information management, and administrative coordination across a range of Regulatory Affairs activities.

Responsibilities may include supporting internal documentation systems (e.g., SharePoint libraries), helping compile and maintain information used for external reporting, assisting with tracking of selected regulatory/standards updates, and contributing to supervised exploratory improvement initiatives (including evaluation of new tools and workflows).

In addition to these core responsibilities, the intern will gain comprehensive exposure to regulatory frameworks governing cell and gene therapy products, providing a unique opportunity to deepen their understanding of the biopharmaceutical industry's regulatory landscape.

ACCOUNTABILITIES:
• Documentation & information management support: Assist with organizing, labeling, and indexing Regulatory Affairs documents; support cleanup of shared folders/document libraries (e.g., SharePoint) using established naming and filing conventions; and flag potentially outdated or duplicate files for team review.
• External reporting & internal tracking support: Assist with gathering, compiling, and entering information for external reporting needs (e.g., WMDA and other agency-related requests) as directed; update internal trackers, reference logs, and status reports; and help prepare materials for internal review of submissions.
• Regulatory/standards monitoring support: Assist with monitoring updates from selected regulatory and standards organizations as assigned; help log and track relevant changes using team templates/tools; and draft brief internal summaries of key updates for team review.
• Exploratory improvement initiatives (supervised): Support supervised pilot activities that evaluate new tools, templates, or process improvements (which may include AI-assisted approaches).
• General team support & learning: Provide general team and operational support as assigned; attend team meetings, training sessions, and learning activities.
• Regulatory insights: Gain hands-on experience with regulatory requirements relevant to innovative therapies (e.g., cell and gene therapies) and applicable U.S.

FDA regulations/guidance (e.g., 21 CFR 1271, 21 CFR 211, 21 CFR 312), as applicable to assigned work.
• Cross-functional support: Provide support to the Regulatory Affairs team for additional activities as needed, such as helping prepare for regulatory meetings and assisting with activity tracking and status updates.
• Knowledge sharing & communication: Summarize key learnings, insights, and recommendations from assigned work and share for broader internal audiences as appropriate.
• Other duties as assigne...