Senior Regulatory Affairs Associate

Role Overview

• 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.