DEPARTMENT: Regulatory Affairs
LOCATION: Durham, NC; Partially Remote COMPANY: Humacyte Inc (Nasdaq: HUMA) is developing a disruptive biotechnology platform to deliver universally implantable bioengineered human tissues, advanced tissue constructs, and organ systems designed to improve the lives of patients and transform the practice of medicine. The Company develops and manufactures acellular tissues to treat a wide range of diseases, injuries, and chronic conditions. Humacyte's initial opportunity, a portfolio of Acellular Tissue Engineered Vessel (ATEVs), is currently approved for use in vascular trauma repair and is in late-stage clinical trials targeting multiple other applications including AV access for hemodialysis and peripheral arterial disease. Preclinical development is also underway in coronary artery bypass grafts, pediatric heart surgery, treatment of type 1 diabetes, and multiple novel cell and tissue applications. Humacyte's 6mm ATEV for AV access in hemodialysis was the first product candidate to receive the FDA's Regenerative Medicine Advanced Therapy (RMAT) designation and has also received FDA Fast Track designation. Humacyte's 6mm ATEV for urgent arterial repair following extremity vascular trauma also received the RMAT designation. For more information, visit . JOB SUMMARY: The Director of Pharmacovigilance (PV) is responsible for leading global drug safety activities and ensuring compliance with regulatory requirements for adverse event (AE) reporting. This position oversees the integrity of safety data across clinical and post-marketing programs, ensuring timely, accurate submissions to global health authorities and effective signal detection, risk management, and safety evaluation processes. The Director provides strategic leadership for PV operations, collaborates cross-functionally with Regulatory Affairs, Clinical Development, and Data Management teams, and drives continuous improvement of PV systems and procedures to uphold patient safety and regulatory excellence. This role also contributes to medical safety strategy development and supports regulatory submissions, including BLAs and clinical study reports. This full-time position may be performed remotely from any location within the continental U.S. and reports to the Head of Pharmacovigilance and Medical Monitoring. Note: This position requires a Doctor of Medicine (MD). ESSENTIAL FUNCTIONS:...About the Role: Alper JCC Miami is seeking an enthusiastic and reliable Basketball Coach to lead youth basketball sessions in a positive, structured, and fun environment. The ideal candidate is passionate about teaching fundamentals, teamwork, and sportsmanship while...
...Time or PRN Dysphagia Management Specialist inPhysician's Office/Clinic Settings, Surrounding Nursing Homes,and a specialized TeleTherapy Portal to help those patients quarantined during this tough time. are available. Would a combination of on-site diagnostics and...
...Job Description Under general medical and nursing direction, you will perform pediatric clinical nursing duties in hospitals, clinics, and community... ...Board of Registered Nursing;AND Clinical Nurse Specialist Certificate: Possession of a valid Clinical Nurse Specialist...
...Sr. React Native Developer HIGHLIGHTS Location: Phoenix, AZ 85024 or Omah a, NE68154 Position Type: Direct Hire Hourly... ...Description: We're seeking a Sr React Native Developer to build high-quality mobile applications that deliver exceptional...
...world-class care. Here, you'll work alongside some of the best clinical talent in the nation leading the way in medical innovation and... ...Paid time off and Holiday pay Description The Clinical Nurse Educator reflects the mission, vision, and values of NM, adheres...