The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.
Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.
Pharmaceuticals, Quality/Risk Management, Regulatory Compliance, US Regulatory Affairs
The Senior Regulatory Affairs Associate will join a team of Regulatory Affairs professionals working together to ensure compliance with regulatory requirements. The team member will help drive our mission of saving lives through cellular therapy through the review of regulatory and clinical documents and submissions, representation on internal and external projects/initiatives and provision of regulatory expertise in key areas such as 21 CFR Part 11 compliance and review of promotional marketing materials.
This team member will work closely with others in the NMDP/Be The Match organization and members of our global cell collection network; support our clinical research partner, the CIBMTR in sponsored IND and IDE studies; collaborate with external global cell and gene therapy industry leaders in developing novel life-saving cell and gene therapies; and communicate and report to external regulatory agencies.
Identifies, assesses, and executes regulatory process improvements, initiatives and projects independently.
Represents NMDP Regulatory Team on interdepartmental projects and to external partners and collaborators.
Serves as primary regulatory expert for 21 CFR Part 11 for the Regulatory Team and on interdepartmental projects.
Performs promotional and other types of marketing material reviews for regulatory compliance.
Reviews, identifies and reports incidents, complaints, and Adverse Events to FDA, HRSA, WMDA and other agencies within appropriate timeframes.
Reviews and approves regulatory and clinical documents (e.g. protocols, amendments, Informed Consents, SOPs) for adequacy and compliance.
Identifies necessary content for submissions and studies; reviews and approves regulatory submissions.
Reviews and presents analysis of data trends with recommendations to mitigate risk or address compliance issues to internal stakeholders.
Understands and effectively communicates content for relevant US FDA regulations/guidance (e.g. 21 CFR 1271, 21 CFR 211, 21 CFR 312, etc.)
Utilize project planning skills to initiate, plan, and execute regulatory projects independently.
Review, collate, analyze, and summarize scientific and technical data.
Utilize Microsoft Word, Excel, PowerPoint, Project, Outlook and to navigate data and record management systems.
Effectively communicate via written and verbal communication, with ability to tailor communications to internal and external audiences.
Organize and prioritize multiple deliverables with competing deadlines.
Work independently and as part of a team.
Collaborate with regulatory peers, cross functional team members, and regulatory agency partners by building strong and effective working relationships.
Education and/or Experience:
B.S. degree or higher in scientific field—typical majors include biochemistry, biological sciences, chemistry, pharmacy, pharmacology, toxicology, medicine, and clinical laboratory science.
3-5 years previous regulatory experience in the device, biologic or pharmaceutical industry
Previous US and/or OUS experience in biologics or cell & gene therapies
Progress towards Regulatory Affairs Certification
Previous publication experience
Previous experience in domestic or international import/export requirements.
Telecommuting is allowed.
Internal Number: 2100003L
About Be The Match / National Marrow Donor Program
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.