ppRevolution 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. /ppOur 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. /ph3The Opportunity /h3pThe 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. /ppWorking 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. /ph3Primary Responsibilities /h3ulliLead European Regulatory Operations and partner with European Regulatory Affairs to translate strategy into submission and lifecycle execution. /liliOwn portfolio submission planning, governance, resourcing, and cross-functional delivery for MAAs, scientific advice, pediatric plans, variations, renewals, and other post-approval submissions. /liliEnsure high-quality, timely, inspection-ready dossiers, eCTD publishing, and submission readiness. /liliOwn 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). /liliBuild and lead the European Regulatory Operations capability, including staff, vendors, budget, capacity, and continuous improvement. /liliAlign regional processes, systems, and standards with Global Regulatory Operations and represent Europe in global governance forums. /li /ulh3Required Skills, Experience and Education /h3ulliBachelor's degree in life sciences or a related discipline; advanced degree preferred. /lili10+ years of progressive regulatory operations, regulatory affairs, or submission-management experience in biotechnology or pharmaceuticals, including European submission leadership. /liliDeep knowledge of European regulatory submissions, eCTD, lifecycle management, and applicable EU regulatory data standards. /liliExperience leading Veeva Vault RIM, regulatory publishing, and EU/regional portal operations. /liliProven ability to lead cross-functional teams, vendors, portfolio governance, and complex submission delivery. /liliExceptional communication, influence, and stakeholder-management skills. /li /ulh3Preferred Skills /h3ulliExperience leading MAAs or other major marketing applications. /liliOncology or rare disease regulatory experience is an advantage. /li /ulpRevolution Medicines takes protection and security of personal data very seriously and respects your right to privacy while using our website and when contacting us by email or phone. We will only collect, process and use any personal data that you provide to us in accordance with our CCPA Notice and Privacy Policy . For additional information, please contact . /pp#LI-Hybrid #LI-LO1 /ppWe are aware of recent recruitment scams in which individuals or organizations falsely represent themselves as being affiliated with Revolution Medicines. These scams may appear as false job advertisements or unsolicited contacts through communication or chat platforms, email, phone, or text message. /ppPlease note that Revolution Medicines does not extend unsolicited employment offers and will never ask candidates to provide financial information, purchase equipment, or pay fees as part of the hiring process. All legitimate communication from Revolution Medicines will come from an official @revmed.com email address. /ppIf you believe you've been contacted by someone impersonating a Revolution Medicines recruiter, please report it to c /p /p #J-18808-Ljbffr
Director, Regulatory Operations, Europe Arbeitgeber: revolutionmedicines
Revolution Medicines ist ein hervorragender Arbeitgeber, der sich durch eine engagierte und innovative Unternehmenskultur auszeichnet. Unsere Mitarbeiter profitieren von umfangreichen Entwicklungsmöglichkeiten und einem unterstützenden Umfeld, das auf wissenschaftlicher Exzellenz basiert. In der Schweiz bieten wir nicht nur die Möglichkeit, an vorderster Front der Onkologie zu arbeiten, sondern auch die Chance, bedeutende Beziehungen zu führenden Experten im Gesundheitswesen aufzubauen und aktiv zur Verbesserung der Patientenversorgung beizutragen.
