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Associate Director, Regulatory Operations
3 months ago
Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) Inhibitors designed to suppress diverse oncogenic variants of RAS proteins, and RAS Companion Inhibitors for use in combination treatment strategies. As a new member of the Revolution Medicines team, you will join other outstanding scientists in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.The Opportunity :Revolution Medicines is seeking a particularly detail-oriented and organized individual with technical expertise to play a much-valued role as publishing lead within the Regulatory Operation function. This position is responsible for managing and executing regulatory publishing activities to ensure timely and accurate submissions to the FDA and other Health Authorities. This role is an individual contributor with team leadership responsibilities, reporting into the head and Director, Regulatory Operations.Manage the production, quality control (QC), delivery and lifecycle of submissions in eCTD format for multiple FDA applications in various drug development phases.Provide expertise in MS Word to format submission documents, including but not limited to creating TOCs, render documents to PDF, bookmark, hyperlink, manage styles, maintain templates.Provide expertise in Adobe to PDF Process and format files to be eCTD compliant including but not limited to clean pages, edit document properties, use hyperlink & bookmark auditor to modify attributes, PDF optimize (Fast Web), skew pages, scaling, images resize and optical character recognition (OCR), and Preflight.Proactively manage multiple and overlapping publishing timelines from initial submission request through archive, anticipating potential delays and working with the teams to communicate and adapt.Effectively manage publishing vendors, consultants, and direct report(s) to support teams and appropriately adjust resources in a dynamic environment.Work with multiple departments across clinical, quality (CMC), and nonclinical to track the creation, versions, organization, review and approval of numerous regulatory documents with competing deadlines.Train teams on procedures, tools, and infrastructure for effective and efficient regulatory publishingMaintain writing resources to ensure that submission documents across functional areas meet internal and health authority standards; resources include style guide, document checklists, and Starting Point templates.Perform gap analysis of regulatory operation policies, processes, and SOPs and initiate activities to support compliance, departmental efficiency, and use of systems.Maintain knowledge of the technical landscape, regulatory operations environment, regulations, and eCTD guidance, providing interpretation to internal stakeholders.Perform other duties, as needed.Required Skills, Experience and Education:8+ years of Regulatory Operations and publishing experienceExpert level proficiency of MicroSoft Word, Adobe Acrobat Professional, Toolbox, StartingPointThorough understanding of eCTD and relevant submission formatting, transmittal and archiving regulations and guidelines; detail oriented and highly organized.Knowledge of ex-US eCTD submissions and submissions processesSuccessfully manage and prioritize multiple FDA applications and submissions deadlines with relative independence.Foster strong collaborative relationships with external partners and vendors to ensure both high quality of submissions and compliance with regulatory processes and standards.Outstanding interpersonal and communication (written and verbal) skills: able to work with multiple groups of people at one time, remaining calm, professional, diplomatic and positive.Preferred Skills:Proficient in IQVIA RIM SMARTProficient in Smartsheet or equivalent project management softwareSubmissions to multiple FDA divisions, especially oncology, experience a plusThe expected salary range for this role is $160,000 to $200,000. An individual’s position within the range may be influenced by multiple factors, including skills and experience in role, overall performance, individual impact and contributions, tenure, and market dynamics. Base salary is one part of the overall total rewards program at RevMed, which includes competitive cash compensation, robust equity awards, strong benefits, and significant learning and development opportunities.Revolution Medicines is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital status, medical condition, and veteran status.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 ourCCPA NoticeandPrivacy Policy.For additional information, please contactprivacy@revmed.com.
