Summer Intern, Regulatory Affairs

Northbrook, IL 60062

Posted: 02/13/2023 Job Number: 36952

Job Description

Pay range is $18 - $22 per hour with full benefits available, including paid time off, medical/dental/vision/life insurance, 401K, parental leave, and more. Our compensation reflects the cost of labor across several US geographic markets. Pay is based on several factors including market location and may vary depending on job-related knowledge, skills, and experience.


Summer Intern, Regulatory Affairs


Intern Position Summary

As a member of the AGT Regulatory Affairs team, the intern will develop and acquire required regulatory skills and knowledge in support of AGT programs. particularly through their internship project and by participating in routine regulatory activities.

The internship project deliverable is an AGT RA position paper. The position paper is intended to convey Regulatory Affairs interpretation and guidance on Regulatory topics (Nonclinical, Clinical, and CMC) related to the development and licensure of AAV Gene Therapy products, including commentary on common themes and issues. This document is intended to support discussions within AGT and be utilized as an educational tool for reference by AGT employees. To facilitate learning in specific programs and the gene therapy space, the intern will review past Health Authority interactions and feedback, current gene therapy guidances and relevant webinars (as available) and interact with both RA and cross-functional colleagues to assist in preparation of the position paper. A final presentation with a high-level overview of the important topics covered in the position paper will be presented to the AGT RA team as well as in the intern symposium.

In addition to the internship project, the intern will have the opportunity to shadow members of the AGT RA team which will allow them to gain exposure to procedures and regulations regarding regulatory submissions, as well as attend internal meetings to participate in strategy discussions for programs ranging from early development to clinical trial phase. Further detail on responsibilities and the internship project can be found below.

Intern Qualifications and Skills
  • Pursuing a bachelor’s or graduate degree in life sciences
  • Must have an interest in pursuing a career in Life Sciences/Biotech/Pharmaceuticals – with an interest in RA
  • Ability to manage workload effectively including planning, organizing, prioritizing, and meeting deadlines
  • Ability to apply scientific and/or business knowledge to assigned projects
  • Effective writing skills, with high attention to detail
  • Proficient in Microsoft Office
This position comes with full benefits, including medical, dental, vision, life, 401k and more!

At Crystal Equation, we empower people and advance technology initiatives by building trust.  Your recruiter will prep you for the interview, obtain feedback, guide you through any necessary paperwork and provide everything you need for a successful start.  We will serve to empower you along the way and provide the path for your professional journey.

Meet Your Recruiter

Scott Brasel

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