Regulatory Affairs Intern
About The Position
Cosette Pharmaceuticals, Inc. is a US-based, fully integrated pharmaceutical company with capabilities in product development, manufacturing, and commercial operations. Cosette has a fast-growing portfolio of branded pharmaceuticals consisting of products in the cardiology, women's health, and migraine markets. Cosette has a long history in quality manufacturing of complex dosage forms including topical creams, ointments, oral liquids/solutions and suppositories, which has led to consistent supply to customers and commercialization success. Cosette has corporate and manufacturing facilities in New Jersey and North Carolina and is supported by more than 300 dedicated employees across all functional areas. Innovating every day.™ Program Overview The Cosette 2026 Summer Internship Program gives students an opportunity for experiential learning in a corporate environment. This is a meaningful, mutually beneficial program where students will bring innovation and drive that will help Cosette reach our goals. In turn, our highly skilled team will help students apply what they already know and broaden their knowledge base. This is an 11-week, full-time program for rising junior and senior undergraduate students at an accredited college or university. The summer internship will run from May 26 - August 7, 2026. Position Summary: 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
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Intern
Number of Employees
251-500 employees
