Regulatory Submissions Planner - Costa Rica
Core
Planning and managing regulatory submission operations, including Original Marketing Applications (OMA) and post-approval submissions, ensuring alignment with strategic target dates across Latin America.
Role type
Regulatory Submissions Planner
Builds
Regulatory submissions and dossiers for pharmaceutical products
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 operations, Project management, eCTD, Latin American regulatory procedures, Regulatory compliance, Dossier assembly, Timeline management, Database management
Preferred skills
Regulatory affairs, Pharmacovigilance, Process improvement
Technologies
Regulatory systems and databases
Responsibilities
Plan and manage regulatory operation projects from authorization to delivery; Develop and maintain regulatory submission plans and milestones; Drive submission assembly and delivery with global/regional teams; Access and maintain regulatory systems and databases; Identify opportunities to improve submission process efficiency.
Seniority
Mid-level, hands-on IC
