2026 Summer Internship - Regulatory Affairs Clinical (Scientific Affairs) Piscataway, NJ

Amneal • Piscataway Township, NJ

8h • Onsite

About The Position

This internship offers exposure to Regulatory Affairs workflows and the end-to-end regulatory submission process. Interns will participate in cross-functional meetings with Regulatory, Clinical, Quality, R&D, and IT partners. A key focus is hands-on experience evaluating and applying AI tools in a regulated environment, including understanding data governance and compliance considerations. The role also provides insight into regulatory intelligence, guidance interpretation, and competitive landscape analysis.

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).
• Ability to apply AI tools to streamline workflows, improve documentation processes, or support regulatory intelligence activities.
• Strong written and verbal communication skills.
• Strong organizational abilities.
• Ability to work collaboratively across teams.
• Background in Clinical Research Management, Regulatory Affairs (Drugs), Pharmaceutical Sciences, Quality Assurance & Regulatory Compliance.

Responsibilities

• AI Tool Evaluation & Pilot Testing (40%) – Own initial assessments, testing, and feedback related to AI tools for RA workflows.
• Process Improvement Using AI (25%) – Support mapping and identifying processes where AI can streamline work or improve efficiency.
• Regulatory Document Review & Summaries (20%) – Use AI tools to support guidance reviews, competitive intelligence, and summary creation.
• Regulatory Data & Knowledge Management (15%) – Assist with organizing regulatory repositories, dashboards, and internal tracking tools.

What This Job Offers

• Career Level: Intern
• Education Level: No Education Listed
• Number of Employees: 1,001-5,000 employees