Regulatory Affairs Specialist

We’re looking for a highly organized and detail-driven Regulatory Affairs Specialist to join our growing clinical research team in Miami. This role is ideal for someone experienced in managing regulatory submissions, maintaining inspection-ready study files, and supporting fast-paced clinical trial operations across multiple sites.

What You’ll Do

• Manage IRB submissions, amendments, and regulatory documentation
• Maintain accurate and audit-ready regulatory files (TMF/eTMF)
• Ensure compliance with FDA, ICH-GCP, and sponsor requirements
• Support study startup, activation, and ongoing trial maintenance
• Collaborate with sponsors, investigators, CROs, and clinical staff

What We’re Looking For

• 2+ years of regulatory experience in clinical research, SMO, or CRO settings
• Strong knowledge of FDA and ICH-GCP guidelines
• Excellent organization and communication skills
• Experience with IRB submissions and multi-study management
• Bilingual English/Spanish is a plus

Join a fast-growing research organization committed to advancing innovative clinical trials and improving patient outcomes.