Associate Director, Regulatory Operations, Europe

About the role

The Associate Director, Regulatory Operations, Europe will play a key role in supporting the growing European Regulatory Affairs organization by leading the operational planning and execution of regulatory submissions across the region. This role partners closely with the European Regulatory Affairs team to operationalize regional regulatory strategies and ensure successful execution of regulatory submissions to health authorities across the EU, EEA, UK and Switzerland. Working cross-functionally with regulatory strategy, clinical, CMC, nonclinical, and quality teams, the Associate Director will drive submission planning, manage regulatory documentation, and coordinate cross-functional teams to deliver high-quality submissions in accordance with global and regional regulatory operations processes and systems. While primarily focused on the European region, this role operates within Global Regulatory Operations and may support regulatory submissions in other regions as business needs evolve. Primary Responsibilities: Serve as the primary Regulatory Operations partner supporting the European Regulatory Affairs team to execute regional regulatory strategies. Lead operational planning, preparation, publishing, and submission of regulatory dossiers to European health authorities including EMA, EU/EEA national authorities, MHRA, and Swissmedic. Lead regulatory submission planning and operational execution for major regulatory applications including Marketing Authorisation Applications (MAA), ensuring effective coordination of submission timelines, dossier assembly, publishing, and submission readiness. Develop and manage detailed regulatory submission timelines, proactively driving cross-functional teams to ensure timely preparation, review, and delivery of submission components. Coordinate cross-functional activities required for regulatory submissions, including document preparation, review cycles, and final submission readiness. Publish and perform quality control of regulatory submissions in eCTD format using DocuBridge, ensuring compliance with applicable regulatory technical requirements. Manage regulatory submission content and metadata within Veeva Vault RIM, ensuring accuracy and completeness of regulatory information and documentation. Support preparation and coordination of key regulatory deliverables including Clinical Trial Applications (CTA), scientific advice packages, pediatric plans, and lifecycle management submissions. Provide operational guidance to cross-functional teams regarding submission requirements, document standards, and regulatory timelines. Partner with Global Regulatory Operations to ensure alignment of regional submission processes, systems, and regulatory documentation standards. Manage external publishing vendors and consultants supporting regulatory submission activities. Provide regulatory operations support for global submissions as needed, collaborating with Global Regulatory Operations colleagues across regions. Manage regulatory procedures via EMA IRIS platform, including scientific advice, orphan designation, and other applicable EMA interactions. Ensure accuracy, completeness, and consistency of structured regulatory data and metadata across Veeva Vault RIM and European health authority systems (e.g., CTIS, IRIS, eSubmission Gateway). Coordinate submission activities across multiple European submission channels and platforms, ensuring alignment of dossier content and data across eCTD and portal-based submissions. Lead operational support for EU regulatory lifecycle activities, including variations, renewals, and other post-approval submissions, ensuring compliance with EU procedural requirements. Required Skills, Experience and Education: Bachelor's degree in life sciences or related discipline. 8+ years of experience in regulatory operations, regulatory affairs, or regulatory submission management within the biotechnology or pharmaceutical industry. Demonstrated experience preparing and publishing eCTD submissions to global health authorities. Strong understanding of European regulatory submission requirements and procedures. Hands-on experience using Veeva Vault RIM for regulatory

Benefits

Additional Information

Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company's R&D pipeline comprises RAS(ON) inhibitors designed to suppress diverse oncogenic variants of RAS proteins. The company's RAS(ON) inhibitors daraxonrasib (RMC-6236), a RAS(ON) multi-selective inhibitor; elironrasib (RMC-6291), a RAS(ON) G12C-selective inhibitor; zoldonrasib (RMC-9805), a RAS(ON) G12D-selective inhibitor; and RMC-5127, a RAS(ON) G12V-selective inhibitor, are currently in clinical development. As a new member of the Revolution Medicines team, you will join other outstanding professionals in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.

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