Regulatory Affairs Specialist-CC

University Overview

The University of Pennsylvania, the largest private employer in Philadelphia, is a world-renowned leader in education, research, and innovation. This historic, Ivy League school consistently ranks among the top 10 universities in the annual U.S. News & World Report survey. Penn has 12 highly-regarded schools that provide opportunities for undergraduate, graduate and continuing education, all influenced by Penn’s distinctive interdisciplinary approach to scholarship and learning.

As an employer Penn has been ranked nationally on many occasions with the most recent award from Forbes who named Penn one of America’s Best Large Employers in 2023.

Penn offers a unique working environment within the city of Philadelphia. The University is situated on a beautiful urban campus, with easy access to a range of educational, cultural, and recreational activities. With its historical significance and landmarks, lively cultural offerings, and wide variety of atmospheres, Philadelphia is the perfect place to call home for work and play.

The University offers a competitive benefits package that includes excellent healthcare and tuition benefits for employees and their families, generous retirement benefits, a wide variety of professional development opportunities, supportive work and family benefits, a wealth of health and wellness programs and resources, and much more.

Regulatory Affairs Specialist-CC

Clinical Research Regulatory Specialist B

The Abramson Cancer Center (ACC) of the University of Pennsylvania is a world leader in developing and conducting innovative clinical trials for the prevention, diagnosis, and treatment of cancer. The ACC One Cancer Clinical Research (OCCR) is instrumental in the development and implementation of cancer clinical trials that offer cutting‑edge oncology treatments. Contingent upon funding.

The ACC OCCR Regulatory Affairs Office seeks a full‑time Regulatory Affairs Specialist-CC to participate in the coordination of Phase I‑V clinical trials. Reporting to the Regulatory Affairs Research Teams Manager, the Regulatory Affairs Specialist-CC will, with minimal supervision, prepare and process all regulatory documentation through the IRB, CTSRMC, FDA and all applicable regulatory review committees—including new submissions, continuing reviews, amendments, adverse events, and reportable events.

He/she will, with minimal supervision, prepare and process all required regulatory documentation for pharmaceutical companies, contract research organizations (CROs), the NCI and the FDA, as well as organize and maintain all regulatory affairs documentation/files as required. The Regulatory Affairs Specialist-CC is expected to resolve regulatory and data queries as required, and participate in initiation, monitoring, audit and close‑out visits. He/she will participate in study team meetings, research team meetings, and ongoing protocol training/compliance meetings.

The Regulatory Affairs Specialist-CC is expected to facilitate the development and submission of FDA IND applications and annual reports, and development/maintenance of study specific case report forms and source document tools, as well as to provide direct regulatory/compliance guidance and facilitate investigator‑initiated trials and investigator‑initiated multi‑site trials. Additional duties relevant to regulatory affairs as assigned.

The successful candidate must have effective problem solving and critical thinking abilities; effective communication and writing skills; strong organizational and time management skills; flexible and able to multi‑task; demonstrated ability to work as part of a team, as well as independently; knowledge of IRB and human research protection regulations, including ICH GCP guidelines. The successful candidate must be self‑driven with heightened attention to detail.

Candidates must desire to work in a fast‑paced environment with competing priorities. Candidates should welcome constructive criticism, be open to learning new approaches, and committed to continued career/professional growth.…