Regulatory Affairs Associate - Full Time - Germantown, Tn

Westcancercenter

Germantown, TN, United States
**
Two years of regulatory affairs experience
Manage institutional review board submissions
Maintain federal regulation compliance
** West Cancer Center is seeking a Regulatory Affairs Associate to manage regulatory submissions and ensure compliance for clinical studies. The ideal candidate should have at least two years of regulatory affairs or research experience, strong organizational skills, and a commitment to patient-centered care. **

Job Summary

  • The Regulatory Affairs Associate I works closely with Sponsors, CROs, investigators, and research staff to coordinate regulatory submissions and approvals for multiple studies.
  • This role is responsible for managing Institutional Review Board (IRB) submissions, maintaining regulatory documentation, processing safety reports, and ensuring compliance with federal regulations.
  • West Cancer Center offers a mission-driven environment with meaningful impact, collaborative culture, professional development opportunities, and no nights, weekends, or holidays.

Matching Summary

Match Score: 75

** West Cancer Center is seeking a Regulatory Affairs Associate to manage regulatory submissions and ensure compliance for clinical studies. The ideal candidate should have at least two years of regulatory affairs or research experience, strong organizational skills, and a commitment to patient-centered care. **

Skills & Requirements

Must-have

  • Two years of regulatory affairs experience
  • Manage Institutional Review Board submissions
  • Maintain federal regulation compliance
  • Process safety reports for studies
  • Interface with sponsors and CROs

Nice-to-have

  • Associate or Bachelor degree preferred
  • Research certification beneficial
  • Strong problem-solving skills
  • Ability to work in multi-functional teams
  • Proficiency in Adobe Acrobat and Excel

Key Requirements

  • Two years of regulatory affairs or research experience
  • Familiarity with Code of Federal Regulations and GCP
  • Associate's or Bachelor's degree (preferred)
  • Research certification (preferred)

Work Rights

Not specified

Tailored Resume

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