Address
Form of workRevolution 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:
This position is responsible for leading and executing regulatory publishing activities to ensure timely and accurate regulatory submissions to the FDA and other Health Authorities.
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.
Manage multiple and overlapping publishing timelines from initial submission request through archive.
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 publishing
Maintain 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 Experience, Skills, and Education:
8+ years of Regulatory Operations experience
Expert level proficiency of MicroSoft Word, Adobe Acrobat Professional, Toolbox, StartingPoint
Proficient in Smartsheet or equivalent project management software
Able to successfully manage and prioritize complex projects to deadlines with relative independence; organized and adaptable to address conflicting deadlines in a dynamic drug development environment.
Thorough 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 processes
Able to foster strong collaborative relationships with external partners, regulatory agencies 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.
Revolution Medicines currently requires that all personnel and visitors to its offices be fully vaccinated against COVID-19. This role will require that the employee meet with company employees and work from the company's offices. Given that these essential functions of the role must be performed on-site, this position requires full COVID-19 vaccination, subject to applicable law.
The 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 our CCPA Notice and Privacy Policy. For additional information, please contact privacy@revmed.com.
