Jefe de Asuntos Regulatorios
Core
Lead regulatory affairs strategy and operations for regulated products including controlled medicines, dietary supplements, and medical devices.
Role type
Senior Regulatory Affairs Manager
Builds
Regulatory compliance and market access for pharmaceutical and medical device portfolios
Domain
Healthcare / Life Sciences
Deliverable
client delivery
Required skills
Regulatory strategy, import permits, health product advertising compliance, regulatory documentation management, stakeholder advisory, legislative interpretation, team leadership
Preferred skills
Experience with controlled substances, audit coordination, regulatory change management
Technologies
Regulatory databases, compliance management systems
Responsibilities
Lead regulatory strategy and operations, manage compliance for controlled medicines and medical devices, coordinate import authorization permits, oversee advertising and promotion regulatory filings, prepare and maintain regulatory dossiers, monitor legislative changes, coordinate regulatory audits, supervise the regulatory team
Seniority
Senior, hands-on IC
