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 / Medical Devices / Regulatory Affairs
Required skills
Regulatory strategy development, product registration (medicines/devices), GMP certification, team leadership, stakeholder management with health authorities, budget management, SOP maintenance, project management, compliance governance, strategic advisory, 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 LOC team in Belarus; develop and execute Belarus/EAEU regulatory strategy for medicines and medical devices; manage state registration procedures and lifecycle maintenance; coordinate GMP application submissions and inspections; oversee local SOPs and regulatory risk management; manage and develop the RA team; liaise with the EAEU Registration Group; control registration dossier deadlines and budget formation.
Seniority
Senior, hands-on IC with leadership responsibilities.