
Regulatory Affairs Clinical Internship
1w1 week agoAmneal Pharmaceuticals
Piscataway, US · Internship · $40,000 – $40,000
About this role
This internship in Regulatory Affairs Clinical (Scientific Affairs) emphasizes AI tools to enhance workflows in a pharmaceutical setting. Interns require foundational coursework in Clinical Research, Regulatory Affairs, Pharmaceutical Sciences, Quality Assurance, or related life-science disciplines. Proficiency in Microsoft Office and familiarity with database systems in regulated environments are essential, along with strong AI and digital competencies.
Daily tasks involve owning AI tool evaluations and pilot testing for RA workflows, supporting process improvements, reviewing regulatory documents, and managing knowledge repositories. Interns apply generative AI and data tools to streamline documentation, guidance reviews, competitive intelligence, and summary creation. Efforts focus on efficiency gains across 40% assessment, 25% process mapping, 20% reviews, and 15% data organization.
Work collaboratively across teams in a regulated pharmaceutical environment at Amneal Pharmaceuticals. Participate in cross-functional meetings with Regulatory, Clinical, Quality, R&D, and IT partners. Strong written and verbal communication supports interactions in this Piscataway, NJ-based role.
Gain exposure to end-to-end regulatory submission processes and AI applications in compliance settings. Develop insights into regulatory intelligence, guidance interpretation, competitive analysis, and data governance. Hands-on experience builds skills in regulated AI tool evaluation and workflow optimization.
Requirements
- Foundational coursework in Clinical Research, Regulatory Affairs, Pharmaceutical Sciences, Quality Assurance, or related life-science disciplines
- Proficiency in Microsoft Office (Word, Excel, PowerPoint)
- Familiarity with database systems or document management tools commonly used in regulated environments
- Strong working knowledge of AI tools (e.g., generative AI, data extraction/analysis tools)
- Strong written and verbal communication skills
- Strong organizational abilities
- Clinical Research Management, Regulatory Affairs (Drugs), Pharmaceutical Sciences, Quality Assurance & Regulatory Compliance
- Minimum cumulative GPA of 3.0
Responsibilities
- Own initial assessments, testing, and feedback related to AI tools for RA workflows
- Support mapping and identifying processes where AI can streamline work or improve efficiency
- Use AI tools to support guidance reviews, competitive intelligence, and summary creation
- Assist with organizing regulatory repositories, dashboards, and internal tracking tools
Benefits
- Paid internship with rates starting at $20/hr based on schooling completed
- Exposure to Regulatory Affairs workflows and end-to-end regulatory submission process
- Participation in cross-functional meetings with Regulatory, Clinical, Quality, R&D, and IT partners
- Hands-on experience evaluating and applying AI tools in a regulated environment
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