Senior Director, Regulatory Affairs, Spain and Portugal
Revolution Medicines · Madrid, Spain
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Role summary
Revolution Medicines seeks a Senior Director of Regulatory Affairs to lead regulatory strategy and compliance activities for Spain and Portugal. The role requires managing regulatory submissions, scientific consultations, promotional approvals, and cross-functional collaboration with global and European teams supporting both early-stage and marketed oncology products.
What they're looking for
- Extensive regulatory affairs experience in pharmaceutical or life sciences industry
- Deep knowledge of ICH requirements and Spanish and Portuguese regulatory frameworks
- Demonstrated leadership experience managing regulatory teams and strategic initiatives
- Experience with marketing authorization applications and post-approval compliance
- Strong cross-functional collaboration and stakeholder management skills
- Knowledge of risk mitigation and healthcare professional communication regulations
What you'll be doing
- Lead regulatory strategy and provide strategic input for assigned projects and territories
- Prepare and coordinate national scientific consultations, pre-submission meetings, and regulatory submissions
- Review and approve promotional materials; manage annual report submissions to authorities
- Monitor regulatory guidelines and communicate updates to regional and global teams
- Manage affiliate inspections, audits, and quality defect handling
Privacy & handoff
This role links to Revolution Medicines's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.