Regulatory Intern - Spring or Summer

Discovery Life Sciences is a leading provider of human biospecimens and cellular starting materials for advancing cell and gene therapy. They are seeking motivated interns to join their Regulatory team, providing hands-on experience in regulatory compliance and quality systems, assisting in gap assessments, regulatory research, and documentation.

Responsibilities

• Perform gap analyses for applicable regulatory requirements, ISO standards, and guidelines
• Identify areas for improvement and document findings
• 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
• 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
• Assist in preparing Institutional Review Board (IRB) annual reports and related documents

Skills

• 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)
• Excellent written and verbal communication skills
• Currently enrolled in a Bachelor's or Master's program in life sciences preferred or other related fields such as legal may be considered
• Some prior experience with Smartsheet would be beneficial

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