POSITION SUMMARY: 

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.

ACCOUNTABILITIES: 

• 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.)