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Revolution Medicines

Clinical-stage oncology company developing RAS inhibitors

Associate Director - Regulatory Science

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours
Full-timeRemote in USARemote

About the Job

Requirements

  • A bachelor's degree in a relevant field; an advanced degree is desirable.
  • At least 9 years in the pharmaceutical or biotechnology industry or relevant work experience, including at least 5 years in Regulatory Affairs.
  • Experience preparing and submitting large, complex regulatory documentation to support health agency review and approval procedures and post-approval activities.
  • Experience representing Regulatory Science on cross-functional teams and presenting to senior management.
  • Strong working knowledge of United States Food and Drug Administration and European Medicines Agency pharmaceutical regulations and guidance.

Responsibilities

  • Develop, implement, and maintain initiatives, processes, and procedures, consulting departmental senior personnel about risks when appropriate.
  • Plan, prepare, and coordinate regulatory submissions, ensuring quality and adherence to timelines.
  • Apply knowledge of regulations, regulatory authority guidance, and industry practices to support organizational objectives.
  • Proactively identify risks and develop mitigation strategies.
  • Serve as a Regulatory Science subject matter expert on cross-functional teams, including study and submission teams.
  • Conduct regulatory research to inform business strategy and assess and communicate risks.
  • Prevent significant business interruptions due to regulatory compliance issues.

Desired Qualifications

  • Experience with European Union Clinical Trials Regulation submissions.
  • Direct experience with oncology drug development.
  • Experience with combination studies and multiple-expansion-cohort, basket, or umbrella master protocols.
  • Direct experience with United States Food and Drug Administration expedited programs.

About the Company

Revolution Medicines

Clinical-stage oncology company developing RAS inhibitors

Revolution Medicines develops precision oncology drugs focused on cancers driven by RAS mutations. Its RAS(ON) inhibitors are small molecules that bind the active form of RAS to block cancer signaling, with candidates like Daraxonrasib (RMC-6236), Elironrasib (RMC-6291), and Zoldonrasib (RMC-9805) advancing in global Phase 3 trials. The company funds its research through collaborations, royalties, and upfront funding, and has not yet marketed a product. Its goal is to bring effective RAS-targeted therapies to patients and advance multiple candidates through late-stage trials toward approval, supported by strong cash reserves.

Company size
1,001-5,000
Company stage
IPO
Headquarters
Redwood City, CA
Founded
2014

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