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
Company Overview