Mirrai Careers

Associate Director, Regulatory Affairs, Europe

Revolution Medicines

Basel, Switzerland Posted 3w ago
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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 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. 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 rigor—all in service of patients. The Opportunity: As part of our expanding European organization, we seek a strategic and hands-on Associate Director, Regulatory Affairs, Europe who will provide regulatory leadership for designated programs at RevMed.  The candidate will be responsible for the preparation & end-to-end execution of regulatory MAA filings across the EU, EEA, UK and Switzerland for oncology programs, ensuring alignment of the European regulatory strategy with the global and regional company`s objectives. They will independently represent regulatory affairs on global and regional cross-functional teams, delivering targeted, strategic and actionable regulatory guidance for oncology programs across one or more therapeutic areas. The candidate must have a thorough understanding of oncology drug development, applicable European regulations and will be supporting engagement with health authorities including the EMA/MHRA/Swissmedic ensuring successful regulatory outcomes. The role will report to the Director, Regulatory Affairs, Europe. Primary Responsibilities: * Research regulatory requirements and identify relevant precendents to develop well-vetted, actionable strategies for assigned programs. * Independently plan, prepare and coordinate regulatory pathways for Marketing Authorisation Applications, and lifecycle management activities in the European Region. * Support regional regulatory planning and oversee integrated filing plans, including timelines, deliverables, and critical path activities. * Coordinate MAA submissions, including dossier readiness, and cross-functional alignment. * Serve, when applicable, as the primary regulatory liaison with European health authorities (e.g., EMA and EU/EEA national agencies), supporting the interactions and communications. * Support preparation and review of key regulatory submissions, including Scientific Advice Briefing Packages, Orphan Designation Applications, and Paediatric Investigation Plans. * Identify, assess, and proactively mitigate regulatory risks impacting timelines or outcomes; communicate progress and risks to Regulatory Affairs leadership. * Partner with regional and global regulatory leads to ensure alignment between global and regional regulatory strategies. * Act as a strategic partner to cross-functional teams, including R&D, Medical Affairs, Safety, Market Access, and Commercial. * Ensure compliance with applicable European regulatory, pharmacovigilance, and governance requirements. * Monitor and interpret evolving European regulatory requirements, guidelines, and trends, and communicate their impact across functions. * Oversee external vendors and CROs to ensure timely, high-quality regulatory submissions and approvals. Required Skills, Experience and Education: * Degree in biological or life sciences, pharmacy, medicine, or related fields. An advanced degree (PhD, PharmD, MSc) is desirable. * A minimum of 8 years in the pharmaceutical/biotech industry or relevant work experience and a minimum of 7 years in Regulatory Affairs including a regulatory strategy role. * Significant experience with oncology drug development highly preferred. * Deep understanding of European regulatory frameworks and oncology guidelines. * Demonstrated success in EMA/MHRA submissions and approvals, including but not limited to MAA , Paediatric, Orphan Designations experience. * Direct hands-on experience in the preparation and submission of large, complex regulatory documentation to support health agency review/approval procedures, post approval activities. * Experience interacting with the EMA and other European agencies. * Demonstrated experience in strategic problem-solving with health agencies and leading internal teams on regulatory strategy. * Experience in representing Regulatory Affairs on cross-functional teams and presenting to senior management. * Excellent interpersonal, written, and presentation skills with the ability to effectively communicate complex regulatory strategies to diverse audiences. * Thrives in fast-paced, dynamic environment and ability to multi-task independently with limited supervision. * Excellent planning and organizational skills and the ability to work simultaneously on multiple projects with tight timelines. * Excellent leadership, communication and stakeholder management skills. * Strong project management and organizational skills. Revolution 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 [email protected]. #LI-Hybrid #LI-LO1 ---------------------------------------- We 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.   Please 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.   If you believe you’ve been contacted by someone impersonating a Revolution Medicines recruiter, please report it to [email protected] so we can share these impersonations with our IT team for tracking and awareness. ----------------------------------------

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