Strategy and Planning Regulatory Affairs Specialist
Core
Develop strategies to introduce new products and therapies and maintain existing products in the Africa & Central Eastern Europe, Turkey, Middle East, Central Asia, and Russia markets.
Role type
Regulatory Affairs Specialist (Strategy & Planning)
Builds
Regional submission plans for new launches and renewals/updates
Domain
Medical Devices / Healthcare Technology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Regulatory affairs expertise, Project management, Critical thinking, Data analysis, Risk identification, Process improvement, Stakeholder collaboration, Documentation management, Timeline tracking, Requirement monitoring
Preferred skills
Strategy planning, Submission preparation, EU MDR knowledge, AI automation tools
Technologies
Copilot
Responsibilities
Build and maintain regional submission plans for new launches and renewals/updates; Liaise with Global Operating Units to manage submission prioritization and address documentary challenges; Represent sub-regions in pre-market submission harmonization and process improvement projects; Identify opportunities for document sharing collaborations across regions; Track submission milestones, identify risks, and report progress; Maintain guidance documents on in-country submission requirements, timelines, and fees.
Seniority
Mid-level, hands-on IC