Director, Regulatory Operations, Europe

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 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 rigorall 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.

Working with senior leaders in regulatory strategy clinical CMC nonclinical quality and Global Regulatory Operations the Director will lead portfolio-level submission planning regulatory information management publishing operations and inspection-ready execution. The Director will build develop and lead a high-performing regional regulatory operations capability including internal staff and external partners while ensuring regional processes systems and data standards scale with the business. While primarily focused on Europe this role operates within Global Regulatory Operations and will influence global standards and support cross-regional priorities as business needs evolve.

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:

• Bachelors 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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