Senior Regulatory Affairs Associate

🔥 39 minutes ago

❄️ Minnesota – Remote

❄️ Minnesota – Remote

⏰ Full Time

🟠 Senior

🚔 Compliance

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NMDP

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1987

🤝 Non-profit

🤲 Charity

🔬 Science

Non-profit • Charity • Science

NMDP is a nonprofit organization (formerly Be The Match) that operates the national blood stem cell donor registry and coordinates cell therapy to treat blood cancers and other blood disorders. It recruits and registers donors, matches donors to patients, facilitates transplants, provides patient support and financial assistance, conducts and funds clinical research and trials, and leads advocacy and fundraising to expand access to life‑saving cell therapies.

📋 Description

• Identifies, assesses, and executes regulatory process improvements, initiatives and projects independently. • 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.

🎯 Requirements

• 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 biologic or pharmaceutical industry. • 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.

🏖️ Benefits

• NMDP offers regular, full-time employees medical, dental, vision, life and disability, accident/critical illness/hospital, well-being, legal, identity theft and pet benefits. • Retirement, paid time off/holidays, leave and incentive plans are also offered to eligible employees.