Associate Director Regulatory Affairs (Immune Health Institute)

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Posted Job Title

Associate Director Regulatory Affairs (Immune Health Institute)

Job Profile Title

Associate Director, Clinical Research Regulatory

Job Description Summary

he Associate Director of Regulatory Affairs will oversee regulatory strategy and compliance for clinical research initiatives within the Penn Colton Center for Autoimmunity, operating under the Institute for Immunology & Immune Health (I3H). Reporting to the Director for Strategic Alliances and Operations, this position will be instrumental in shaping and implementing regulatory frameworks that support innovative, translational research while ensuring compliance with all applicable regulations and institutional requirements. Key responsibilities include anticipating regulatory changes, planning for organizational growth across Penn, and liaising with regulatory groups across the Perelman School of Medicine, the University of Pennsylvania Health System, and federal government agencies.

Job Description

Strategic Leadership and Regulatory Oversight

· Serve as the primary authority on regulatory affairs matters, overseeing regulatory strategy and compliance across the Colton Center's and the broader I3H portfolio

· Establish and maintain Standard Operating Procedures (SOPs) for regulatory programs, ensuring adherence to University of Pennsylvania and all applicable regulatory requirements

·Lead regulatory strategy development for Colton Moonshot program, including protocol development, case report forms, and source document tools

Drive strategic planning for clinical research regulatory operations while anticipating and adapting to regulatory changes

Stakeholder Engagement and Partnerships

· Serve as key departmental representativ