Regulatory Affairs Associate - Full Time - Germantown, TN
On-site · Germantown, Tennessee, United States
Job Summary
Regulatory Affairs Associate I coordinates regulatory submissions and IRB approvals for multiple studies, maintains regulatory documentation, processes safety reports, and ensures compliance with federal regulations while supporting ongoing research activities. Responsibilities include maintaining study binders, preparing and submitting documents to IRB/Sponsors/FDA, managing site changes and amendments, obtaining IRB approval for updated materials, interfacing with sponsors, CROs, IRBs, and FDA, and contributing to training and orientation of new employees. Key skills include regulatory knowledge (CFR, GCP), strong organizational and communication abilities, ability to manage multiple priorities, and proficiency with common software tools. No nights, weekends, or holidays are required; location is Germantown, TN (US). The role emphasizes collaboration with Sponsors, CROs, investigators, and research staff to coordinate regulatory activities and ensure study compliance.
Required Qualifications
- Two (2) years of regulatory affairs or research experience
- Preferred: Associate’s or Bachelor’s degree
- Research certification (preferred)
- Strong organization and follow-up skills
- Excellent verbal and written communication skills
- Familiarity with Code of Federal Regulations and Good Clinical Practice (GCP)
- Ability to organize and prioritize work assignments
- Ability to manage multiple priorities in a fast-paced environment
- Ability to analyze situations and respond in a timely manner
- Ability to work in multi-functional teams
- Proficiency in Word, Excel, Adobe Acrobat, email, and internet research
- No nights, weekends, or holidays is mentioned in the description but comprehensive benefits package is noted
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