Intern, Clinical Regulatory Affairs

Position 

This 10-week summer internship provides an opportunity to gain hands-on experience within the Regulatory Affairs function in a collaborative, fast-paced clinical development environment. The Regulatory Affairs Intern will support regulatory intelligence, development landscape assessment, and regulatory communication workflow initiatives that help guide global drug development strategies. 

In this role, you will gain exposure to regulatory strategy, clinical development planning, and regulatory communication processes. This internship is designed to provide experience working with regulatory intelligence databases, analyzing clinical trial landscape data, and supporting regulatory documentation and communication workflows that support program advancement. 

About You 

You are interested in learning how regulatory strategy supports drug development and are excited to work with scientific data, clinical trial information, and regulatory documentation. You are detail-oriented, analytical, and comfortable synthesizing complex scientific information into clear written summaries and presentations. You are organized, collaborative, and motivated to learn how regulatory teams support clinical development programs. 

 What You’ll Do 

• Perform research to drive development of regulatory strategy for a clinical development program.
• Utilize regulatory intelligence and public clinical trial databases to conduct development landscape assessments.
• Review publicly available regulatory documents (e.g., FDA approval summaries, advisory committee materials) to identify common regulatory considerations and decision drivers.
• Develop and maintain MS Excel trackers summarizing relevant clinical trial information, including indication, phase, patient population, endpoints, and other key study attributes.
• Analyze clinical trial and regulatory landscape data to support internal program planning.
• Review regulatory communications related to active development programs.
• Support development of written summaries and slide decks that outline regulatory communication workflows and internal review processes.
• Support internal regulatory knowledge management by organizing guidance documents, terminology, and key learnings.  
• Assist with updates and quality review of internal regulatory tracking tools and documentation.
• Present internship project outcomes and key learnings. 

Qualifications 

• Currently enrolled in an accredited university pursuing a Bachelor’s or graduate-level degree in Biology, Chemistry, Pharmacology, Life Sciences, or a related discipline.
• Entering junior year of a bachelor’s program or currently enrolled in a graduate-level degree program at the start of the internship.
• Must be enrolled in school during the internship program.
• Background in life sciences with completion of coursework in technical or scientific writing.
• Basic understanding of drug development and pharmacology principles.
• Strong proficiency in Microsoft Word, Excel, and PowerPoint.
• Strong analytical skills with ability to interpret scientific and clinical information.
• Strong written and verbal communication skills with attention to detail.
• Ability to organize and synthesize complex information into clear summaries and presentations.
• Ability to work collaboratively in a team environment while managing multiple deliverables.
• Must be available to work full-time (40 hours per week) during core business hours for a minimum of 10 weeks during the summer internship program. 

The expected hourly pay range for this role is $36 - $48/hour. Placement within this range is determined based on education level.