Regulatory Affairs Lead, Belarus
Core
Lead the regulatory function in Belarus and drive national and EAEU regulatory strategy to ensure product availability and business continuity in the Belarus market and across the EAEU region.
Role type
Senior Regulatory Affairs Lead (Belarus/EAEU)
Builds
Product registrations, lifecycle maintenance, and GMP certifications for medicines and medical devices in Belarus and the EAEU.
Domain
Pharmaceuticals and Medical Devices in Belarus and the Eurasian Economic Union (EAEU)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Regulatory strategy development, product registration (medicines/devices), lifecycle management, GMP certification coordination, team leadership, stakeholder management with health authorities, budget management, SOP maintenance, regulatory risk management, project management, strategic advisory, audit process leadership, AI tool proficiency for regulatory monitoring.
Preferred skills
None stated.
Technologies
RIM systems, AI tools for regulatory monitoring and document refinement.
Responsibilities
Lead the RA team in Belarus to meet timelines and KPIs; develop and execute regulatory strategies for product approvals and lifecycle management; liaise with the EAEU Registration Group; manage state registration procedures and dossier submissions; coordinate GMP application submissions and inspections; oversee local SOPs and regulatory compliance; manage the RA team's performance and development; provide expert guidance to market access and medical affairs functions; maintain up-to-date information in RIM systems.
Seniority
Senior, hands-on IC with team leadership