Regulatory Specialist

About the position

The department of Medicine, division of Pulmonary Medicine, has an exciting opportunity for a full-time Regulatory Specialist to work on the UHealth campus. The Regulatory Specialist assists with the preparation and maintenance of files, binders, and required program documentation for regulatory submissions.

Responsibilities

• Facilitates the process of regulatory document submissions to various boards, committees, industry sponsors, and state and federal agencies.
• Collects and maintains credentialing information, research education records, studies, safety reports, and other required program documentation.
• Assists during audits and site visits for matters concerning regulatory compliance.
• Submits or assists in the submission of applications for institutional clinical trials, state and/or federal programs, and grants.
• Assists in the development, training, and education of staff members.
• Maintains current knowledge of applicable regulatory topics.
• Adheres to University and unit-level policies and procedures and safeguards University assets.
• Prepare, review, and submit all regulatory documents, including Institutional Review Board submissions, amendments, continuing reviews, and safety reports.
• Ensure compliance with local, state, and federal regulations (FDA, NIH, ICH-GCP) and institutional policies.
• Oversee regulatory start-up activities for new clinical trials, including site feasibility assessments and submission of site initiation packages.
• Manage regulatory close-out activities, ensuring final reporting to IRB and sponsors.
• Develop and update SOPS to streamline regulatory workflows and enhance compliance.

Requirements

• Bachelor's Degree in relevant field
• Minimum 1 year of relevant experience
• 1 Year experience working with the Institutional Review Board (IRB) highly desired

Benefits

• Competitive salaries
• Comprehensive benefits package including medical, dental, tuition remission and more