Regulatory Affairs Intern

Bristol Myers Squibb•Indianapolis, IN

5d•$24 - $45•Onsite

About The Position

The Regulatory Affairs Intern will support the Regulatory Affairs team in preparing documentation, tracking submissions, and assisting with project coordination. This internship offers exposure to regulatory processes in the pharmaceutical industry and provides hands-on experience in a cross-functional environment. The full-time internship will take place June - August 2027 at our Indianapolis site.

Requirements

Currently pursuing a Bachelor’s degree in Life Sciences, Pharmacy, Public Health, or related field
Strong interest in regulatory affairs and drug development
Excellent organizational and communication skills
All candidates must be authorized to work in the US both at the time of hire and for the duration of their employment. Please note that immigration or visa sponsorship is not available for this position.

Nice To Haves

Familiarity with Microsoft Office Suite (Word, Excel, PowerPoint, Outlook) and Adobe Acrobat
Experience with project management tools (e.g., Smartsheet, MS Project) is a plus
Prior internship or coursework related to clinical trials or regulatory science
Detail-oriented and able to manage multiple tasks
Strong written and verbal communication skills
Professional, proactive, and eager to learn
Ability to work collaboratively in a dynamic, cross-functional environment

Responsibilities

Regulatory Documentation Support: Assist in organizing and formatting regulatory submission documents (e.g., IND, CTA, briefing packages, nonclinical reports), Help maintain submission trackers and document repositories, Review documents for consistency and completeness under supervision.
Project Coordination: Support the creation and updating of project timelines and task lists, Attend team meetings and take notes on action items and follow-ups, Help prepare meeting agendas and distribute materials.
Cross-functional Communication: Coordinate with internal teams to gather required documentation, Draft internal communications and summaries for regulatory updates, Shadow cross-functional meetings to understand regulatory integration.
Research and Compliance: Conduct literature reviews and regulatory intelligence gathering, Assist in compiling summaries of relevant FDA/EMA guidance documents, Help monitor changes in regulatory requirements and flag updates to the team.