Director, European Regulatory Operations & Submissions

Revolution Medicines, Inc.; Basel; Hybrid; CHF 260.000 - 360.000; Vollzeit

Zusammenfassung

Revolution Medicines is seeking a Director, Regulatory Operations, Europe to provide strategic and operational leadership for European regulatory submissions across the EU, EEA, UK and Switzerland. You will own portfolio submission planning, governance, and lifecycle management, partner with Regulatory Affairs, and lead Veeva Vault RIM and regional portals.

This role requires 10+ years in biotech/pharma regulatory operations and a proven ability to drive complex submissions with cross-functional

Qualifikationen

• Bachelor’s degree in life sciences or related field; advanced degree preferred.
• 10+ years of regulatory operations, regulatory affairs, or submission-management experience in biotechnology or pharmaceuticals, including European submission leadership.
• Deep knowledge of European regulatory submissions, eCTD, lifecycle management, and applicable EU regulatory data standards.

Aufgaben

• Lead European Regulatory Operations and partner with European Regulatory Affairs to translate strategy into submission and lifecycle execution.
• Own portfolio submission planning, governance, resourcing, and cross-functional delivery for MAAs, scientific advice, pediatric plans, variations, renewals, and other post-approval submissions.
• Ensure high-quality, timely, inspection-ready dossiers, eCTD publishing, and submission readiness.
• Own Veeva Vault RIM and all EU and regional regulatory submission portals, gateways, and systems, including data governance, submission tracking, data quality, and applicable EU data standards (e.g., SPOR/IDMP).
• Build and lead the European Regulatory Operations capability, including staff, vendors, budget, capacity, and continuous improvement.
• Align regional processes, systems, and standards with Global Regulatory Operations and represent Europe in global governance forums.

Kenntnisse

Regulatory leadership

Stakeholder management

Regulatory submissions

Ausbildung

Bachelor’s degree in life sciences

Advanced degree preferred

Tools

Veeva Vault RIM

eCTD publishing

Jobbeschreibung

Revolution Medicines is seeking a Director, Regulatory Operations, Europe to provide strategic and operational leadership for European regulatory submissions across the EU, EEA, UK and Switzerland. You will own portfolio submission planning, governance, and lifecycle management, partner with Regulatory Affairs, and lead Veeva Vault RIM and regional portals.

This role requires 10+ years in biotech/pharma regulatory operations and a proven ability to drive complex submissions with cross-functional