University of Florida - Details - Research Regulatory Manager-Department of Neurosurgery-GMP Lab

Research Regulatory Manager-Department of Neurosurgery-GMP Lab

Apply now Job no: 539032
Work type: Staff Full-Time
Location: Main Campus (Gainesville, FL)
Categories: Grant or Research Administration
Department:29190000 - MD-NEUROLOGICAL SURGERY

Classification Title:	Research Regulatory Manager
Classification Minimum Requirements:	Bachelor's degree and four years of relevant experience; or an equivalent combination of education and experience.
Job Description:	Provides Quality Management Oversight to GMP projects •Responsible for coordinating all GMP document control for all operational units in the GMP Group. •Prepares and issues all working copies of manufacturing production documents and QC testing documents. •Audits all GMP Facilities, Manufacturing and Quality Control documentation for accuracy and compliance with GMP Regulations. •Reviews and approves all deviation and investigation reports from Facilities, Manufacturing and Quality Control. •Reviews and approves all Quality Control Assay Qualification Protocols. Audits and approves all QC qualification reports. •Reviews and audits all Facilities, Manufacturing and Quality Control facility and equipment calibration/validation. Reviews and approves all equipment installation/operational qualification protocols and associated reports. •Reviews and releases/rejects all raw materials used for Facilities, Manufacturing and Quality Control. Provides Regulatory Support to GMP projects •Works with the Director of GMP and Project Sponsors to ensure all GMP projects comply with Federal Regulations. Regularly reviews FDA publications and notifications for relevant information/updates. •Works with the Director of GMP and Project Sponsors to ensure compliance with ongoing reporting requirements including IRB and FDA initial protocol IND/IDE submissions, annual reports, study amendments, safety reports, and unanticipated problem/noncompliance reports. Serves as primary liaison to regulatory bodies. •Assists with the development, drafting and subsequent revision of all Chemistry, Manufacturing and Controls (CMC) with the Director of GMP and Project Sponsors for all Investigational New Drug (IND) Applications. •Facilitates all sponsor-directed or regulatory mandated inspections/audits. This includes hosting and drafting, review and transmittal of any associated reports. Provides GMP and Regulatory Training for GMP Personnel •Provides annual GMP regulatory training for all GMP Personnel. •Maintains standards for GMP Manufacturing and Quality Control operational conduct and integrity, and ensures compliance with GMP Regulations. Provides supervision of regulatory staff
Expected Salary:	Salary commensurate with education and experience.
Required Qualifications:	Bachelor's degree and four years of relevant experience; or an equivalent combination of education and experience.
Preferred:	At least 3 years GMP Manufacturing, Quality Control or Quality Management (or previous regulatory experience).
Special Instructions to Applicants:	For consideration, please complete an application and include a cover letter, resume and the names and email addresses of three to five references. The University of Florida is an Equal Employment Opportunity Employer. Application must be submitted by 11:55 p.m. (ET) of the posting end date.
Health Assessment Required:	Yes

Advertised: 06 Mar 2026 Eastern Standard Time
Applications close: 19 Mar 2026 Eastern Daylight Time

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Position	Department	Location	Closes
Research Regulatory Manager-Department of Neurosurgery-GMP Lab	29190000 - MD-NEUROLOGICAL SURGERY	Main Campus (Gainesville, FL)	19 Mar 2026
The Quality and Regulatory Manager described herein works in the Clinical and Translational Science Institute (CTSI) Cellular and Gene Therapy Core which is charged with responsibility for medical education, medical care, and clinical research activities for Cellular and Gene Therapy Core. The incumbent is responsible for Quality Management and regulatory functions of assigned GMP projects. The Lillian S. Wells Department of Neurosurgery at the University of Florida, College of Medicine is committed to providing comprehensive clinical services for the diagnosis, management, treatment, and rehabilitation of patients suffering from diseases of the brain, spinal cord, and nervous system, including brain tumors, aneurysms, stroke, epilepsy, functional disorders, and spinal disorders and injuries. Our clinical care mission also extends throughout North Central Florida through regional neurosurgery programs. We offer the full spectrum of neurosurgical and neuro-oncology treatment options for both adults and pediatric patients. Our research labs and investigator-led initiatives and clinical trials are developing promising new treatments for neurological diseases that are extremely difficult to treat with conventional therapies. The Department of Neurosurgery offers education and training programs such as ACGME-accredited neurosurgery residency programs and fellowship programs.