Senior Regulatory Affairs Associate
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Job Description
Senior Regulatory Affairs Associate in NMDP advancing regulatory compliance for clinical and regulatory submissions across cell and gene therapies. Collaborating with internal and external partners to ensure adherence to regulatory requirements.
Responsibilities:
- The Senior Regulatory Affairs Associate will join a team of Regulatory Affairs professionals.
- Support the review of regulatory and clinical documents and submissions.
- Participate on internal and external projects/initiatives.
- Provide regulatory support in key areas such as 21 CFR Part 11 compliance.
- Work closely with others in the NMDP organization and global cell collection network.
- Assist with regulatory oversight and submissions for trials where NMDP is the Sponsor of an IND or international equivalent.
- Support clinical trials, protocols and/or INDs under NMDP Master Protocol.
- Serve as primary regulatory expert for 21 CFR Part 11 for the Regulatory Team and interdepartmental projects.
- Perform promotional and marketing material reviews for regulatory compliance.
- Review incidents, complaints, and Adverse Events to FDA, HRSA, WMDA and other agencies.
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 device, biologic or pharmaceutical industry
- 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).
- 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.
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.
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