"Regulatory Specialist C"

Regulatory Specialist C

Job Profile Title: Clinical Research Regulatory Specialist C

Job Description Summary

Regulatory Affairs as a field is concerned with ensuring that clinical research is conducted in a safe and legally compliant manner. Regulatory Affairs staff are often the interface between PIs, product manufacturers (including internal at Penn), regulatory bodies (both internal and external) and research participants. Regulatory Affairs staff assist in obtaining and maintaining institutional and governmental approval for clinical trials. These trials often include FDA-regulated products, including drugs, medical devices, nutritional products and related materials. Regulatory Affairs Specialists must understand the applicable regulations and the roles and responsibilities of sponsors, vendors, clinical researchers, and government officials.

Regulatory Affairs Specialist C will lead the coordination of unit research, including but not limited to Phase I-IV clinical trials. The Regulatory Affairs Specialist C will, independently prepare and process all regulatory documentation/applications for the FDA and requisite review committees...

Job Responsibilities

• Regulatory Affairs Specialist C will lead the coordination of unit research, including but not limited to Phase I-IV clinical trials...
• The Regulatory Affairs Specialist C functions independently with minimal supervision on complex protocols that are Investigator Initiated...
• The Regulatory Affairs Specialist C reviews relevant safety information...
• The Regulatory Affairs Specialist C will serve as a mentor and/or trainer to more junior members of the regulatory research team/study team.

Qualifications

Bachelor's degree and 5 to 7 years of experience or equivalent combination of education and experience is required. Associated research credentialing (ACRP, RAC, CCRP, CIP, etc.) preferred.

The successful candidate must have effective problem solving and critical thinking abilities; effective communication and writing skills; strong organizational and time management skills...

Working Conditions

Hybrid Eligible - This position is eligible for a hybrid work schedule... This position is intended to be largely remote.

Targeted Pay Range

$77,920 - $85,907

Job Location: Philadelphia, Pennsylvania

Department / School: Perelman School of Medicine

Pay Range: $74,500.00 - $85,000.00 Annual Rate

To apply, visit https://wd1.myworkdaysite.com/en-US/recruiting/upenn/careers-at-penn/job/HUP/Regulatory-Specialist-C_JR00110626-1