What are the responsibilities and job description for the Regulatory Affairs Specialist position at Green Life Science?
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.