Associate Director, Regulatory Operations, Europe

Revolution Medicines seeks an Associate Director for Regulatory Operations in Basel to lead the planning and execution of regulatory submissions across Europe, ensuring compliance and timely delivery to health authorities.

This position serves as the operational backbone for the European Regulatory Affairs organization. The incumbent will partner closely with regional teams to translate regulatory strategies into actionable plans, managing the end-to-end execution of submissions to authorities in the EU, EEA, UK, and Switzerland. While the primary focus is Europe, the role also integrates with Global Regulatory Operations to support broader business needs.

Responsibilities

• Act as the main operational partner for the European Regulatory Affairs team to drive regional strategy execution.
• Oversee the planning, preparation, and submission of regulatory dossiers to key authorities such as the EMA, MHRA, Swissmedic, and national bodies.
• Direct the operational workflow for major applications, including Marketing Authorisation Applications (MAA).
• Create and manage detailed submission timelines, coordinating cross-functional teams to ensure components are reviewed and delivered on schedule.
• Orchestrate cross-functional activities, including document preparation, review cycles, and final readiness checks.
• Publish and quality-control regulatory submissions in eCTD format using DocuBridge, adhering to technical regulatory standards.
• Maintain accuracy and completeness of regulatory content and metadata within Veeva Vault RIM.
• Support the preparation of key deliverables such as Clinical Trial Applications (CTA), scientific advice packages, pediatric plans, and lifecycle management submissions.
• Provide operational guidance to internal teams regarding submission requirements, document standards, and timelines.
• Collaborate with Global Regulatory Operations to align regional processes, systems, and documentation standards.
• Manage relationships with external publishing vendors and consultants involved in submission activities.
• Provide operational support for global submissions as required, working with colleagues across different regions.
• Handle regulatory procedures via the EMA IRIS platform, including scientific advice and orphan designation interactions.
• Ensure consistency and accuracy of structured regulatory data and metadata across Veeva Vault RIM and health authority systems.
• Coordinate submission activities across multiple European channels, ensuring dossier content aligns between eCTD and portal-based submissions.
• Lead operational support for EU lifecycle activities, including variations and renewals, ensuring compliance with procedural requirements.

Requirements

• Bachelor’s degree in life sciences or a related field.
• At least 8 years of experience in regulatory operations, affairs, or submission management within biotech or pharma.
• Proven track record of preparing and publishing eCTD submissions to global health authorities.
• Deep understanding of European regulatory submission requirements and procedures.
• Hands-on experience with Veeva Vault RIM for regulatory information management.
• Practical experience using DocuBridge for regulatory publishing.
• Ability to lead submission timelines and coordinate cross-functional deliverables.
• Strong knowledge of regulatory document management, publishing standards, and lifecycle processes.
• Demonstrated capacity to manage multiple complex submissions simultaneously while maintaining quality and compliance.
• Excellent organizational, communication, and stakeholder management skills.
• Familiarity with the EMA IRIS platform and associated procedures like scientific advice and orphan designation.
• Experience managing regulatory data, metadata, and tracking across multiple health authority systems.

Nice to have

• Experience supporting submissions to EMA, MHRA, Swissmedic, or EU national competent authorities.
• Background in supporting Marketing Authorisation Applications (MAA) or other major marketing applications.
• Experience working within global regulatory teams on regional and global submissions.
• Oncology or rare disease regulatory experience is considered an advantage.
• Experience managing regulatory publishing vendors or external consultants.
• Background in growing or evolving regulatory organizations.
• Knowledge of EU regulatory procedures, including centralized, decentralized, or mutual recognition pathways.
• Familiarity with evolving EU regulatory data standards, such as SPOR/IDMP.

About the company

Revolution Medicines is a late-stage clinical oncology company dedicated to developing novel targeted therapies for patients with RAS-addicted cancers. The company’s research and development pipeline focuses on RAS(ON) inhibitors designed to suppress diverse oncogenic variants of RAS proteins. The team is deeply committed to addressing the needs of patients with cancers harboring mutations in the RAS signaling pathway.

• Focus on developing novel targeted therapies for RAS-addicted cancers.
• Commitment to patients with cancers harboring mutations in the RAS signaling pathway.
• Pipeline centered on RAS(ON) inhibitors to suppress diverse oncogenic variants.