Senior Regulatory Affairs Specialist (Office of Clinical Research)

University of Pennsylvania • Philadelphia, PA

412d • $59,703 - $95,524

About The Position

The Senior Regulatory Affairs Specialist at the University of Pennsylvania will serve as the project and regulatory lead for university-held INDs, IDEs, and foreign CTAs. This role involves providing clinical operations leadership, managing project teams, and ensuring compliance with government and institutional policies throughout the clinical trial life cycle. The specialist will also support and train potential Sponsors of Investigator Initiated Trials, contributing to the development of essential documentation and operational processes.

Requirements

• Prior experience in drug or device clinical trials.
• Experience implementing ICH regulations.
• Project management experience is essential.

Nice To Haves

• Experience in a university or academic research environment.
• Familiarity with regulatory submissions and compliance processes.

Responsibilities

• Support faculty Sponsors and serve as the project and regulatory lead for university held INDs, IDEs, and foreign CTAs.
• Provide clinical operations leadership and contribute to the review of core documents.
• Manage the Sponsor trial master file and prepare submissions to Health Authorities.
• Provide day-to-day project support and develop operational processes to ensure compliance with policies.
• Support, train, and qualify potential IND/IDE/CTA Sponsors throughout the clinical trial life cycle.
• Aid in the development of Sponsor documents such as consent forms and safety monitoring plans.

Benefits

• Comprehensive medical, prescription, behavioral health, dental, vision, and life insurance benefits.
• Tuition assistance for employees and their dependents.
• Generous retirement plans including Basic, Matching, and Supplemental options.
• Substantial time away from work for personal needs.
• Long-term care insurance options available.
• Wellness and work-life resources to support health and balance.
• Professional and personal development resources.
• Access to university resources and cultural activities.
• Discounts and special services for faculty and staff.
• Flexible work hours and options.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Educational Services
• Education Level: No Education Listed