Summer Intern, Regulatory Affairs
As a member of the Regulatory Affairs team, the intern will develop and acquire required regulatory skills and knowledge in support of programs. particularly through their internship project and by participating in routine regulatory activities
The internship project deliverable is an 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 and be utilized as an educational tool for reference by 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 guidance 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 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 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
Project Related Responsibilities:
- Review of applicable Gene Therapy Guidance Documents to research and gain understanding of the health authority viewpoint(s) as related to the topics of the project
- Review of Global Regulatory submission documents to obtain correspondence information and feedback between and the health authority agency
- Review gene therapy specific webinars, as available, on current hot topics to further learning in gene therapy space. Provide high-level summaries to RA team.
- Utilize knowledge gained from research activities to prepare draft of RA position paper, for review by manager, buddy, and other applicable RA team members
- Prepare a final presentation on research, and overall learning through the internship project for the intern symposium
Additional Regulatory Responsibilities:
- Support the team in preparation (including requesting, drafting, editing & formatting) of a maintenance regulatory submission (e.g., SUSARs, protocol amendments, etc.)
- Attend internal meetings with cross-functional team members and trainings, as appropriate.
- Participate in discussions regarding development of regulatory strategy for programs
- Review program specific documents and provide feedback, as appropriate
Benefits of the Internship
Introduction and exposure to Regulatory Affairs strategy from a nonclinical, clinical, and CMC aspect - specific to gene therapy (GT) development. Intern will also learn about the role and importance of regulatory operations. Overall project, as described above, introduces intern to interpreting Agency feedback, reviewing health authority guidance and cross-functional collaboration while providing an overall regulatory foundation and understanding of the GT space. Lastly, the intern will gain hands-on, real-world experience, in routine activities as a regulatory professional.
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