"Associate Director, Regulatory"

Job Description

The University of Pennsylvania, a world-renowned Ivy League institution, is seeking an Associate Director, Regulatory to oversee clinical research regulatory operations.

Job Description Summary

With oversight from the Director, the Associate Director for Regulatory Affairs will manage the department/division's clinical research portfolio, provide strategic planning, oversee regulatory staff, and liaise with various regulatory groups.

Job Responsibilities

• Oversee clinical research portfolio and assist in strategic planning for regulatory operations.
• Directly oversee, train, and mentor regulatory staff, monitor workloads, and ensure compliance.
• Serve as the primary authority on regulatory matters for investigators and staff.
• Represent the department in interactions with internal and external regulatory entities, including IRB, FDA, and others.
• Assist in protocol development, resource planning, and tracking of research studies.
• Oversee regulatory submissions, documentation, and quality assurance.
• Perform other duties as assigned.

Qualifications

Bachelor's degree and 7-10 years of experience required; Master's preferred. ACRP and/or RAC certification needed. Expertise in GCP, FDA regulations, and clinical research processes is essential. Strong organizational, communication, and problem-solving skills required.

Job Location

Philadelphia, Pennsylvania (Hybrid eligible).

Department / School

Perelman School of Medicine.

Pay Range

$105,500.00 - $130,000.00 annually.

University Benefits

• Health, life, and flexible spending accounts.
• Tuition benefits for employees and families.
• Retirement plans.
• Time away from work, long-term care insurance, wellness resources, professional development, and more.

For more details, visit: https://www.hr.upenn.edu/PennHR/benefits-pay