Coordinador de Asuntos Regulatorios Corporativo Giro Farmaceutico
Core
Ensure regulatory compliance, manage administrative procedures with health authorities, and maintain quality standards for health supply storage, distribution, and sales.
Role type
Corporate Regulatory Affairs Coordinator
Builds
Compliance with health regulations and quality standards for pharmaceutical supply chain operations
Domain
Healthcare / Pharmaceutical distribution
Deliverable
dashboards & analysis
Required skills
Regulatory compliance, administrative procedures, quality policy supervision, internal/external audit management, product registration, importation of controlled medicines, regulatory platform usage (DIGIPRIS, VUCEM)
Preferred skills
Knowledge of Mexican official regulations (NOM059, NOM241, NOM072, NOM137, NOM220, NOM240, NOM249), stability protocols, label projects
Technologies
DIGIPRIS, VUCEM
Responsibilities
Monitor regulatory compliance, manage COFEPRIS procedures, train staff, supervise quality policies, conduct internal/external audits, review quality agreements and product registration documents, request equipment/materials, track permit and resolution statuses
Seniority
Mid-level, hands-on IC