Regulatory Affairs Intern
About The Position
The Regulatory Affairs intern will gain hands-on exposure to compiling Annual Reports and Periodic Adverse Drug Experience Reports (PADERs) that are filed to the FDA. They will also learn how to create labels and patient information for Branded and Generic products. This role offers a unique opportunity to understand how regulatory strategy directly enables product development, approval, and post-marketing success, while working alongside experienced regulatory professionals in a collaborative, mission-driven environment. The internship provides a strong foundation for a future career in regulatory affairs or related functions within the pharmaceutical industry.
Requirements
- Experience with MS Word and PDF
- Ability to learn new software
Nice To Haves
- Currently pursuing a bachelor’s degree in chemistry, pharmacy, regulatory science or related discipline
Responsibilities
- Learn content and format of Annual Reports and compile Annual Reports for New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs)
- Learn content and format of PADERs and compile PADERs for NDAs and ANDAs
- Create and review Labels and Patient Information
- Learn Electronic Common Technical Document (eCTD) software and compile submissions
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Intern
Number of Employees
251-500 employees
