2026 Summer Internship - Regulatory Affairs Clinical (Scientific Affairs) Piscataway, NJ
Job
Amneal Pharmaceuticals LLC
Piscataway, NJ (In Person)
Full-Time
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Job Description
Position Overview:
Relevant Coursework:
Foundational coursework in Clinical Research, Regulatory Affairs, Pharmaceutical Sciences, Quality Assurance, or related life‑science disciplines.Technical Skills:
Proficiency in Microsoft Office (Word, Excel, PowerPoint) and familiarity with database systems or document management tools commonly used in regulated environments.AI & Digital Competency:
Strong working knowledge of AI tools (e.g., generative AI, data extraction/analysis tools) and the ability to apply them to streamline workflows, improve documentation processes, or support regulatory intelligence activities.Professional Skills:
Strong written and verbal communication skills, strong organizational abilities, and the ability to work collaboratively across teams.Key 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.
Qualifications:
- Clinical Research Management, Regulatory Affairs (Drugs),
Pharmaceutical Sciences, Quality Assurance & Regulatory Compliance What You'll Gain:
- Exposure to Regulatory Affairs workflows and the 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, including understanding data governance and compliance considerations.
- Insight into regulatory intelligence, guidance interpretation, and competitive landscape analysis.
Education:
- High School diploma or GED—Required
- Current full-time enrollment in an accredited college or university undergraduate or graduate program in Human Resources, Business Administration, Psychology, or a related field—Required
- Minimum cumulative GPA of 3.
Required Additional Requirements:
- Must be at least 18 years old
- Must be legally authorized to work in the United States
- Must commit to the full duration of the internship (all interns must start no later than June 1, 2026
- August 28, 2026.
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