Regulatory Intern

About Discovery Life Sciences:

Position Summary:

Must-Have Qualifications (Education, Skills, Experience):

• Currently enrolled in a Bachelor’s or Master’s program in life sciences preferred or other related fields such as legal may be considered
• Interest in regulatory compliance and quality systems in the biotechnology industry
• Strong attention to detail and organizational skills
• Ability to conduct research and interpret complex concepts
• Proficient in Microsoft Office Suite (Excel, Word, PowerPoint). Some prior experience with Smartsheet would be beneficial
• Excellent written and verbal communication skills

Key Responsibilities:

Regulatory Gap Assessments:

• Perform gap analyses for applicable regulatory requirements, ISO standards, and guidelines
• Identify areas for improvement and document findings

Management Review Support:

• Assist in evaluating changes to regulatory requirements impacting the Tissue Biomarker Services sites (US and EU)
• Prepare summaries and reports for management review meetings related to regulatory requirements

Database Development:

• Compile a list of applicable local regulations for each site
• Create and maintain a comprehensive database of regulatory requirements for:

• GCLP (Good Clinical Laboratory Practice)
• ISO 17020
• Other relevant standards and guidelines

IRB Reporting Support:

• Assist in preparing Institutional Review Board (IRB) annual reports and related documents

Compensation and Benefits:

• This is a “for credit” internship. The selected candidate will not be entitled to compensation, benefits, or paid time off.

Location and work hours:

• Hybrid – Ideally located in the Huntsville, AL or Newtown, PA area; Remote applicants will be considered
• -time – 5 to 20 hours per week during the Spring 2026 semester
• Applications for this position will be accepted until the role has been filled.