Country Regulatory Specialist, Clinical Research - 100% Remote in Brazil, English advanced
Core
Manage country-level regulatory operations and submissions for clinical trials from startup to project end, serving as the main contact with Regulatory Authorities and Ethics Committees.
Role type
Country Regulatory Specialist (Clinical Research)
Builds
Regulatory submissions, country intelligence, and compliance documentation for clinical trials
Domain
Life Sciences / Clinical Research / Regulatory Affairs
Required skills
Clinical trial process knowledge (Phases I-IV), ICH GCP, GxP regulations (GVP, GCP, ISO 14155), country-specific regulatory submission processes, regulatory intelligence management, stakeholder management with RAs/ECs
Preferred skills
BA or BS degree, 3-4 years experience in clinical research or regulatory area, ability to work independently and in teams
Technologies
Microsoft Office Suite, web-based regulatory systems
Responsibilities
Prepare and submit Central EC, Local EC, RA, and hospital approval applications; maintain country regulatory intelligence; forecast submission timelines and track milestones; interact directly with Regulatory Authorities and Ethics Committees; support site selection and business development presentations; ensure document compliance with Trial Master File (TMF) SOPs; develop local regulation training materials.
Seniority
Mid-level, hands-on IC
