Manages the NMDP Regulatory Compliance Program within Quality & Regulatory Services (QRS) in support of the organization’s strategic objectives to assure continuing compliance with USA Food and Drug Administration (FDA) cellular therapy regulations and promote highest standards of safety for donors, patients and products. Primary accountabilities include: provision of regulatory expertise to internal staff, senior leadership, and Network partners to promote and ensure ongoing operational compliance with FDA regulations; serves as a key liaison to the FDA for communication and submission of regulatory reports; manages the QRS Audit Program, the QRS Quality Control Unit (QCU), and team of regulatory compliance staff.
Bachelor’s Degree in medical technology, biology, biotechnology, or other science related field. Graduate degree desired. Regulatory Affairs Certification required.
Minimum of seven years of experience in a quality, regulatory or project management position within an FDA regulated industry such as blood, tissue, drug, medical device. Experience managing IND and/or biologics licensure and regulatory submissions to FDA (IND, BLA, IDE, 510(k), PMA) preferred. Advanced degree may substitute for some experience.
Demonstrated applied knowledge of regulatory requirements for pharmaceutical, biologic or medical device required. Demonstrated applied knowledge of Good Manufacturing Practices (GMP) and Good Tissue Practices (GTP) required.
Ability to meet deadlines and manage multiple projects and tasks simultaneously; manage and provide leadership to staff; excellent oral and written communication; strong analytical skills; work independently and as part of a team; strong interpersonal and customer service skills. Flexible, collaborative and adaptive working style. Proficiency in Microsoft Office Suite applications. Demonstrated program management to include participation in budget development and administration, supervision, strategic operational planning and program implementation.
The National Marrow Donor Program® is a leader in the field of cellular transplantation. We partner with a global network of hospitals, blood centers, cord blood banks, and laboratories to facilitate bone marrow transplants for patients with life-threatening illnesses such as leukemia and lymphoma. The NMDP also operates the Be The Match™ Registry, conducts vital research to improve survival and q...uality of life, and provides education and support services to health care professionals and patients. Our staff helps deliver this cutting-edge science, service and support to patients and their families.