Senior Regulatory Affairs Associate

This is a fully remote position, open to applicants in Minnesota.

📋 Description

• Identifies, evaluates, and implements improvements to regulatory processes, initiatives, and projects autonomously.

• Represents the NMDP Regulatory Team in interdepartmental projects and engages with external partners and collaborators.

• Aids in regulatory oversight and submissions for trials where NMDP acts as the Sponsor of an IND or its international equivalent.

• Supports clinical trials, protocols, and/or INDs under the NMDP Master Protocol, utilizing the Platform design.

• Acts as the primary regulatory expert for 21 CFR Part 11 for the Regulatory Team and within interdepartmental projects.

• Conducts reviews of promotional and other marketing materials to ensure regulatory compliance.

• Reviews, identifies, and reports incidents, complaints, and Adverse Events to the FDA, HRSA, WMDA, and other relevant agencies within stipulated timeframes.

• Reviews and approves regulatory and clinical documents (e.g., protocols, amendments, Informed Consents, SOPs) for adequacy and compliance.

• Identifies essential content for submissions and studies; reviews and approves regulatory submissions.

• Analyzes data trends and presents findings with recommendations to mitigate risks or address compliance issues to internal stakeholders.

• Understands and effectively conveys relevant US FDA regulations/guidance (e.g., 21 CFR 1271, 21 CFR 211, 21 CFR 312, etc.).

• Delivers exceptional and responsive customer service to both internal colleagues and external partners.

⛳️ Requirements

• A B.S. degree or higher in a scientific field—common majors include biochemistry, biological sciences, chemistry, pharmacy, pharmacology, toxicology, medicine, and clinical laboratory science.

• 3-5 years of prior regulatory experience in the biologic or pharmaceutical sector.

• Capability to apply project planning skills to initiate, organize, and independently execute regulatory projects.

• Ability to review, collate, analyze, and summarize scientific and technical data along with regulatory guidance.

• Leverage an understanding of the product lifecycle and apply it to NMDP products and clients.

• Proficient in utilizing Microsoft Word, Excel, PowerPoint, Project, Outlook, and navigating data and record management systems.

• Implement new technology-enhanced methods of working (including technology automation and AI-assisted tools) to aid in document preparation, review workflows, and information organization.

• Communicate effectively in both written and verbal forms, with the ability to tailor messages for internal and external audiences.

• Organize and prioritize multiple deliverables that have competing deadlines.

• Capable of working independently as well as collaboratively within a team environment.

• Build strong and effective working relationships with regulatory peers, cross-functional team members, and regulatory agency partners.

🏝️ Benefits

• NMDP provides regular, full-time employees with medical, dental, vision, life and disability, accident/critical illness/hospital, well-being, legal, identity theft, and pet benefits.

• Eligible employees are also offered retirement plans, paid time off/holidays, leave, and incentive programs.