POSITION SUMMARY:
The Senior Regulatory Affairs Associate will join a team of Regulatory Affairs professionals working together to ensure compliance with regulatory requirements. This role supports the review of regulatory and clinical documents and submissions, participation on internal and external projects/initiatives, and provision of regulatory support in key areas such as 21 CFR Part 11 compliance.
This team member will work closely with others in the NMDP 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 partners in developing novel life-saving cell and gene therapies; and communicate and support reporting activities with external regulatory agencies.
ACCOUNTABILITIES:
• Identifies, assesses, and executes regulatory process improvements, initiatives and projects independently. This includes use of digital tools and automation (e.g., templates, workflows, structured data capture) to improve efficiency and quality.
• Represents NMDP Regulatory Team on interdepartmental projects and to external partners and collaborators.
• Assists with regulatory oversight and submissions for trials where NMDP is the Sponsor of an IND or international equivalent.
• Supports clinical trials, protocols and/or INDs under NMDP Master Protocol, using the Platform design.
• 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.)
• Provides excellent and responsive customer service to internal colleagues and external partners.
REQUIRED QUALIFICATIONS:
Ability to:
• Utilize project planning skills to initiate, plan, and execute regulatory projects independently.
• Review, collate, analyze, and summarize scientific and technical data and regulatory guidance.
• Leverage understanding of the product lifecycle and apply it to NMDP products and clients.
• Utilize Microsoft Word, Excel, PowerPoint, Project, Outlook and to navigate data and record management systems.
• Apply new technology-enabled ways of working (including technology automation and AI-assisted tools) to support document preparation, review workflows, and information organization.
• 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
PREFERRED QUALIFICATIONS: (Additional qualifications that may make a person even more effective in the role, but are not required for consideration)
• Previous US and/or OUS experience in biologics or cell & gene therapies
• Previous regulatory experience in a Clinical Research Organization (CRO) setting
• Exposure to submissions throughout the drug/product lifecycle
• Exposure to process automation and/or AI-assisted tools used in regulated environments (e.g., document management, workflow tools, data extraction or summarization tools).
• Progress towards Regulatory Affairs Certification