Revolution Medicines

Revolution Medicines

Manager, Global Regulatory Affairs Project Management

Redwood City, California, United States · Full-time

Sponsorship not specified$143k-$178kDetected 1 day ago
ComplianceProject ManagementFDA RegulatoryLeadershipCommunicationBiostatisticsRegulatory Affairs

About the role

  • Facilitate Global Regulatory Teams and meetings to ensure coordinated development and execution of high-quality, timely global regulatory deliverables at the study level.
  • Champion innovation and operational excellence, identifying opportunities to streamline regulatory project management and enhance submission preparation efficiency and scalability.

Responsibilities

  • Maintain and communicate integrated submission plans and schedules, proactively tracking progress, identifying risks and dependencies, and implementing mitigation strategies to support on-time regulatory milestones and agency interactions.
  • Partner with Global and Regional Regulatory Science Leads to support the execution of global regulatory strategies for assigned molecules across indications.
  • Propose and support implementation of operational solutions, including process improvements, as appropriate.
  • Partner with the Director, Global Regulatory Affairs Project Management to build and maintain submission dashboards; communicate status, risks, and mitigation strategies to key stakeholders.
  • Support the development, implementation, and continuous improvement of global regulatory project management processes, templates, tools, dashboards, analytics, and best practices.
  • Partner with the Director, Global Regulatory Affairs Project Management to lead regulatory submission activities from initiation through submission, defining scope, priorities, timelines, resource requirements, risks, and key deliverables to ensure successful execution.
  • Strong project management skills with proven ability to manage multiple complex programs under compressed timelines in a fast-paced, cross-functional environment that values both speed and quality.

Requirements

  • Bachelor's degree in a life sciences or related discipline with 5+ years of pharma / biotech industry experience, including 3+ years of regulatory project management experience.
  • Working knowledge of CTD structure and dossier component management, including coordination across cross-functional filing team contributors and senior leadership.
  • Working knowledge of global regulatory regulations, guidelines, and submission pathways
  • familiarity with nonclinical, clinical, and CMC (bio)pharmaceutical development.

Nice to have

  • High proficiency with project management tools including Smartsheet and Microsoft Project, and familiarity with WBS management, timeline development, and critical path analysis
  • experience with OnePager, Office Timeline, and Veeva RIM is a plus.

Skills

  • Oncology drug development experience.
  • Hands-on US IND and NDA application experience
  • #LI-JC1 #LLI-Hybrid
  • The base pay salary range for this full-time position for candidates working onsite at our headquarters in Redwood City, CA is listed below.

Compensation

  • $143,000 - $178,000 USD
  • 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.

Benefits

  • Required Skills, Experience and Education:

Company info

  • Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers.
  • The company's R&D 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.
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This listing is sourced directly from Revolution Medicines's careers page and normalized into a canonical job model.