Regulatory Lead, Clinical Research

Perelman School of Medicine at the University of Pennsylvania; United States; On-site; USD 76,000 - 78,000; Full time

Job summary

The Perelman School of Medicine at the University of Pennsylvania in Philadelphia seeks a Clinical Research Regulatory Specialist C to lead regulatory management for NIH and industry-sponsored trials in the Neuroradiology Clinical Research Division. The role involves overseeing submissions to IRBs, committees, sponsors, CROs, FDA, and regulatory agencies with a focus on compliance and process improvement.

You will develop regulatory tools, provide expert guidance, and mentor junior staff while

Qualifications

• Bachelor's degree and 5 to 7 years of experience or equivalent combination of education and experience is required.
• Experience leading regulatory operations for NIH and industry-sponsored trials is preferred.
• Ability to manage complex regulatory submissions and provide training to junior staff.

Responsibilities

• Lead regulatory operations for NIH and Industry-sponsored clinical trials in the Neuroradiology Clinical Research Division.
• Independently manage submissions to IRBs, committees, sponsors, CROs, FDA, and regulatory agencies.
• Oversee regulatory documentation, resolve complex compliance issues, and train junior staff.
• Act as liaison for regulatory oversight with investigational teams, nursing units, sponsors, and CROs.

Skills

Regulatory management

IRB submissions

Documentation

Stakeholder liaison

Education

Bachelor's degree

Job description

The Perelman School of Medicine at the University of Pennsylvania in Philadelphia seeks a Clinical Research Regulatory Specialist C to lead regulatory management for NIH and industry-sponsored trials in the Neuroradiology Clinical Research Division. The role involves overseeing submissions to IRBs, committees, sponsors, CROs, FDA, and regulatory agencies with a focus on compliance and process improvement.

You will develop regulatory tools, provide expert guidance, and mentor junior staff while