Director, Regulatory Operations, Europe

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 a global, commercial-state oncology company dedicated to discovering, developing and delivering innovative medicines for patients with RAS-addicted cancers. Leveraging its differentiated RAS(ON) tri-complex inhibitor platform, the company is advancing a broad, integrated portfolio of oral RAS(ON) inhibitors designed to directly target the active, cancer-driving state of RAS. Founded on rigorous scientific inquiry and a willingness to challenge long-held assumptions, Revolution Medicines is committed to changing the trajectory of disease for patients with RAS-addicted cancers worldwide.

Our people are united by a shared way of working: follow the science, challenge assumptions, act with urgency and hold ourselves to a high standard of rigor—all in service of patients.

The Opportunity:

The Director, Regulatory Operations, Europe will provide strategic and operational leadership for European regulatory operations, establishing the operating model, capabilities, and governance required to deliver a growing portfolio of high-quality regulatory submissions. This role is the senior Regulatory Operations partner to the European Regulatory Affairs organization, translating regional regulatory strategy into integrated submission and lifecycle execution across the EU, EEA, UK, and Switzerland.

Primary Responsibilities:

• 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.

Required Skills, Experience and Education:

• Bachelor’s degree in life sciences or a related discipline; advanced degree preferred.
• 10+ years of progressive 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.
• Experience leading Veeva Vault RIM, regulatory publishing, and EU/regional portal operations.
• Proven ability to lead cross-functional teams, vendors, portfolio governance, and complex submission delivery.
• Exceptional communication, influence, and stakeholder-management skills.

Preferred Skills:

• Experience leading MAAs or other major marketing applications.
• Oncology or rare disease regulatory experience is an advantage.

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