What are the responsibilities and job description for the 2025 Summer Internship - Regulatory Affairs Clinical position at Amneal?
The intern will work alongside experienced professionals, gaining insight into regulatory compliance and clinical study oversight.
Key Responsibilities:
- Support project management, including tracking action items and project milestones.
- Assist with the management of databases related to project strategies, clinical studies, and investigator audits.
- Contribute to authoring regulatory submissions, including meeting requests, controlled correspondence, and PADERs (Periodic Adverse Drug Experience Reports).
- Assist in the organization and tracking of clinical study documentation.
- Collaborate with teams to ensure regulatory compliance and data accuracy.
Qualifications & Skills:
- Currently pursuing a degree in Clinical Research, Regulatory Affairs, Pharmaceutical Sciences, or Chemistry.
- Completed coursework related to the areas of study above.
- Proficiency in Microsoft Office Suite.
- Strong computer skills, including database management.
- Excellent communication, teamwork, and organizational skills.
Benefits of the Internship:
- Gain hands-on experience in regulatory affairs and clinical research.
- Work alongside industry professionals and expand your professional network.
- Develop skills in regulatory compliance, project management, and clinical documentation.
Qualifications:
Education:
- High School diploma or GED—Required
- Current full-time enrollment in an accredited college or university undergraduate or graduate program—Required
- Minimum cumulative GPA of 3.0—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 10-12-week duration of the internship.
To be considered, candidates must meet all the above criteria.
