Regulatory Affairs Intern
Bristol Myers Squibb
Summary
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.
Job description
The full-time internship will take place June - August 2027 at our Indianapolis site.
Responsibilities
- 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
- 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
- Coordinate with internal teams to gather required documentation
- Draft internal communications and summaries for regulatory updates
- Shadow cross-functional meetings to understand regulatory integration
- 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
Basic Qualifications
- 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.
Preferred Qualifications
- 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
Skills and Attributes
- 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
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.
- 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
Benefits
- Inclusion
- Wellbeing
- Flexibility
- Comprehensive benefits
Company overview
Bristol Myers Squibb is a global biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines that help patients prevail over serious diseases. Founded in 1887 and headquartered in Princeton, New Jersey, the company operates with a unique BioPharma strategy that combines the reach and resources of a major pharmaceutical company with the entrepreneurial spirit and agility of a biotech firm. BMS focuses on transformative therapies in key therapeutic areas including oncology, hematology, immunology, cardiovascular disease, and fibrosis. The company has built a sustainable pipeline of potential therapies and leverages translational medicine and data analytics to deliver the right medicine to the right patient at the right time. With over 10,000 employees worldwide, Bristol Myers Squibb maintains a strong commitment to scientific excellence, patient-centric innovation, and global health equity through its foundation. The company's portfolio includes groundbreaking treatments such as Opdivo (nivolumab) for cancer, Eliquis (apixaban) for cardiovascular conditions, and Orencia (abatacept) for autoimmune diseases, among others.