The Director, Regulatory Affairs will lead a team of Regulatory Affairs professionals and will own developing and delivering innovative, breakthrough global regulatory strategies. This role will guide the organization through regulatory submission/approval processes and oversee reporting to global regulatory agencies. This leader will deliver regulatory direction to NMDP organization and members of our global cell collection network; support our clinical research partner the CIBMTR in sponsored IND and IDE studies; and collaborate with external global cell and gene therapy industry leaders in developing novel life-saving cell and gene therapies.
Establishes and implements the NMDP Regulatory Plan and the Regulatory Affairs department strategy. Establishes goals and priorities to mitigate risk and to ensure regulatory compliance with required regulations and established internal standards.
Monitors changes in regulations (FDA, EMA, TGA, HealthCanada and PMDA/MHLW); assesses compliance implications; and engages NMDP leaders with solutions to minimize risk and to ensure realization of strategic plans.
Assures regulatory resources are provided in the planning and execution of strategic initiatives, core projects, and on clinical studies.
Drives thorough assessment of the regulatory impact of changes, projects and initiatives including those impacting NMDP standards, procedures, and labeling. Provides direction on application of external standards.
Ensures incidents, complaints, and Adverse Events are identified, documented, and reported to FDA, HRSA, WMDA and other agencies within appropriate timeframes.
Ensures consignees notification of nonconforming HCT/P products.
Serves as Regulatory staff liaison with NMDP Standards Committee. Ensures completion of standards revisions based on established cycle times. Works with committee on submitted variances as needed.
Provides training, guidance and interpretation of regulations and GCP guidelines to the NMDP organization and department team members.
Evaluates regulatory and clinical documents (e.g. protocols, amendments, Informed Consents, SOPs) for adequacy and compliance.
Performs IND regulatory submissions, including approval, event-driven and annual Reviews content of clinical documents to ensure studies are designed in compliance to standards and guidance. Participates on study teams in a regulatory/clinical quality role.
Drives content for submissions and oversees collection of required documentation reporting activities for complex studies.
Reviews and provides analysis of data trends with recommendations to mitigate risk or address compliance issues.
Assists with follow-up activities to assure that non-compliance issues are addressed with satisfactory resolution.
Maintains a working knowledge in the specific areas related to GCP compliance including, but not limited to regulatory US FDA regulations/guidance documents and ICH guidelines.
Thorough understanding of FDA regulatory submission requirements and ongoing reporting.
Strong knowledge of GTP and GCP regulations.
Project Management and Quality Management.
Requirements of IND/IDE Management and the principles of Clinical Quality Assurance.
Lead and develop a team of Regulatory Affairs professionals.
Oversee the implementation of strategic plans, meeting of key deadlines, and managing multiple projects and tasks simultaneously.
Write and communicate articulately and concisely.
Tailor communication to internal and external audiences.
Produce high-quality work on complex problems with cross-functional involvement.
Education and/or Experience:
B.S. degree or higher in scientific field or equivalent regulatory/scientific experience.
Minimum 5 years of team development and management experience.
Minimum 8 years of regulatory and/or clinical quality experience in the biotechnology field.
Minimum 3 years of clinical trial submission experience.
Advanced Degree and/or RAC preferred.
Practical experience in assessing compliance to US FDA and international regulations, GTPs, and GCPs.
Internal Number: 190000GL
About Be The Match
We’re trusted leaders in the field of cellular therapy. We never lose sight of our purpose—delivering cures for blood cancers. From the moment a patient is diagnosed, we are there every step of the way; helping their doctor find a donor, delivering life-saving cells to the patient’s bedside, and supporting patients through recovery and survivorship.
With over 30 years of experience, we are the trusted leaders in advancing the science of transplant, conducting ground-breaking research and providing vital services for patient families when they need them most.
As the world’s largest registry and hub of a global network, our partners count on us to develop innovative solutions to improve transplant and fuel collaborative relationships essential to saving lives.