Regulatory Submissions Planner - Costa Rica
Core
Planning and managing regulatory submission operations for Original Marketing Applications (OMA) and post-approval submissions across the Latin America region.
Role type
Regulatory Submissions Planner
Builds
Regulatory submissions and dossiers for Health Authorities
Domain
Pharmaceutical regulatory affairs in Latin America
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Regulatory submission planning, Project management, eCTD, Regulatory compliance, Technical writing, Regulatory reporting, Regulatory strategy development, Regulatory communications, Regulatory experience, Regulatory affairs management
Preferred skills
Pharmacovigilance, Electronic Common Technical Document (eCTD), Employee Training Programs, Pharmaceutical Regulatory Affairs, Regulatory Affairs Compliance, Regulatory Affairs Management, Regulatory Communications, Regulatory Compliance, Regulatory Experience, Regulatory Reporting, Regulatory Strategy Development, Regulatory Submissions, Technical Writing
