StellenbeschreibungppRevolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS‑added cocktails of cancers. The company’s RD 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. /p h3The Opportunity /h3 pThe 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, non‑clinical, 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. /p h3Primary Responsibilities /h3 ul liServe as the primary Regulatory Operations partner supporting the European Regulatory Affairs team to execute regional regulatory strategies. /li liLead operational planning, preparation, publishing, and submission of regulatory dossiers to European health authorities including EMA, EU/EEA national authorities, MHRA, and Swissmedic. /li liLead 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. /li liDevelop and manage detailed regulatory submission timelines, proactively driving cross‑functional teams to ensure timely preparation, review, and delivery of submission components. /li liCoordinate cross‑functional activities required for regulatory submissions, including document preparation, review cycles, and final submission readiness. /li liPublish and perform quality control of regulatory submissions in eCTD format using DocuBridge, ensuring compliance with applicable regulatory technical requirements. /li liManage regulatory submission content and metadata within Veeva Vault RIM, ensuring accuracy and completeness of regulatory information and documentation. /li liSupport preparation and coordination of key regulatory deliverables including Clinical Trial Applications (CTA), scientific advice packages, pediatric plans, and lifecycle management submissions. /li liProvide operational guidance to cross‑functional teams regarding submission requirements, document standards, and regulatory timelines. /li liPartner with Global Regulatory Operations to ensure alignment of regional submission processes, systems, and regulatory documentation standards. /li liManage external publishing vendors and consultants supporting regulatory submission activities. /li liProvide regulatory operations support for global submissions as needed, collaborating with Global Regulatory Operations colleagues across regions. /li liManage regulatory procedures via EMA IRIS platform, including scientific advice, orphan designation, and other applicable EMA interactions. /li liEnsure 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). /li liCoordinate submission activities across multiple European submission channels and platforms, ensuring alignment of dossier content and data across eCTD and portal‑based submissions. /li liLead operational support for EU regulatory lifecycle activities, including variations, renewals, and other post‑approval submissions, ensuring compliance with EU procedural requirements. /li /ul h3Required Skills, Experience and Education /h3 ul liBachelor’s degree in life sciences or related discipline. /li li8+ years of experience in regulatory operations, regulatory affairs, or regulatory submission management within the biotechnology or pharmaceutical industry. /li liDemonstrated experience preparing and publishing eCTD submissions to global health authorities. /li liStrong understanding of European regulatory submission requirements and procedures. /li liHands‑on experience using Veeva Vault RIM for regulatory information management. /li liHands‑on experience using DocuBridge for regulatory publishing. /li liDemonstrated ability to lead regulatory submission timelines and coordinate cross‑functional submission deliverables. /li liStrong understanding of regulatory document management, publishing standards, and regulatory submission lifecycle processes. /li liProven ability to manage multiple complex regulatory submissions simultaneously while maintaining high quality and compliance. /li liStrong organizational, communication, and stakeholder management skills. /li liFamiliarity with EMA IRIS platform and associated regulatory procedures. /li liExperience managing regulatory data, metadata, and submission tracking across multiple health authority systems and platforms. /li /ul h3Preferred Skills /h3 ul liExperience supporting regulatory submissions to European health authorities including EMA, MHRA, Swissmedic, or EU national competent authorities. /li liExperience supporting Marketing Authorisation Applications (MAA) or other major marketing applications. /li liExperience working in global regulatory teams supporting both regional and global regulatory submissions. /li liOncology or rare disease regulatory experience is considered an advantage. /li liExperience managing regulatory publishing vendors or external regulatory consultants. /li liExperience working within a growing or evolving regulatory organization. /li liExperience navigating EU regulatory procedures (centralised, decentralised, or mutual recognition). /li liFamiliarity with evolving EU regulatory data standards (e.g., SPOR/IDMP) is a plus. /li /ul /p #J-18808-Ljbffr
