Experteer Overview
In this role you drive regulatory strategy and execution for Spain and Portugal within a late-stage oncology company focused on RAS-pathway therapies. You will lead regulatory activities and provide cross-functional input to ensure compliant, timely development and commercialization. You will collaborate with global and regional teams to navigate ICH and EU requirements, shaping for both early-stage programs and marketed products. This is an opportunity to influence regulatory decisions in a high-impact, fast-paced environment and support patient access to innovative cancer therapies.

Compensaciones / Beneficios
• Provide regulatory leadership for assigned projects and territories across early and late-stage programs
• Coordinate creation of materials for risk mitigation and healthcare professional communication
• Ensure accuracy and updates of product packaging and labeling
• Review and approve promotional materials; manage submissions and annual reports
• Represent regulatory function in internal and external meetings with regional/global RA
• Monitor and interpret national regulatory guidelines and communicate implications to teams
• Contribute to regulatory guideline development and communicate changes to project teams




• Lead local/global process improvements and supervise regulatory-related procedures including SOPs
• Oversee affiliate inspections, audits, quality defects, recalls, and distribution licenses
• Manage local regulatory compliance audits and budget/resource planning
• Provide vision and direction for the RA organization at country level in line with general/European RA
• Ensure staff readiness through training and hiring as needed
• Adhere to company values and understand customer engagement requirements for field teams
• Travel up to 30% to support regulatory activities

Responsabilidades
• Master's or PhD in scientific or medical discipline
• 12+ years in regulatory leadership or similar roles in pharma/biotech
• Strong understanding of Spain/Portugal and EU regulatory frameworks
• Experience in oncology
• Excellent verbal and written communication, presentation, and scientific summarization skills
• Proven ability to build relationships with regulatory bodies and healthcare professionals
• Independent, fast-paced, and dynamic work style
• Willingness to travel up to 30%

Requisitos principales
•

📌 Senior Director, Regulatory Affairs, Spain and Portugal (Madrid)
🏢 Revolution Medicines
📍 Madrid