Regulatory Scientist
Core
Prepare, review, and coordinate regulatory documentation and submission packages for clinical trials to Health Authorities and Ethics Committees in Colombia.
Role type
Regulatory Scientist (Clinical Trials)
Builds
Regulatory submission packages for clinical trial execution and product development
Domain
Healthcare / Clinical Research / Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Regulatory documentation preparation, submission package coordination, compliance with ICH-GCP guidelines, regulatory system management (CTMS, eTMF), cross-functional collaboration, regulatory landscape monitoring, agency interaction support
Preferred skills
Global or regional clinical trial submission experience, Colombia and LATAM regulatory processes knowledge, study start-up activities understanding
Technologies
CTMS, eTMF
Responsibilities
Prepare and review regulatory documentation, ensure timely delivery within quality standards, track submission documentation, collaborate with Clinical Operations and Safety teams, monitor regulatory changes, support agency interactions
Seniority
Mid-level, hands-on IC
