Revolution Medicines

Revolution Medicines

Senior Director, Molecule Global Regulatory Lead

Redwood City, California, United States · Director · Full-time

Sponsorship not specified$244k-$305kDetected 23 hours ago
ComplianceNegotiationFDA RegulatoryLeadershipCommunicationCollaborationRegulatory Affairs

About the role

  • This leader will shape innovative and efficient regulatory pathways that enable rapid, science-driven development while positioning assets for long-term success.
  • The position reports to the Head of Regulatory Sciences and serves as a key member of the Regulatory leadership team.
  • Monitor the evolving global regulatory environment and provide regulatory intelligence that informs development strategy, competitive positioning, and organizational decision-making.

Responsibilities

  • Develop, own, and execute the global regulatory strategy for assigned molecule(s) from IND-enabling activities through registration and lifecycle management.
  • Serve as the accountable global regulatory lead for assigned molecule(s), ensuring regulatory strategies support corporate objectives, development milestones, and global registration plans.
  • Develop innovative regulatory approaches that enable efficient clinical development and maximize opportunities for expedited pathways.
  • Anticipate regulatory risks, evaluate potential impact, and develop proactive mitigation strategies.
  • Provide strategic guidance for the preparation of briefing documents, meeting requests, responses to agency questions, and regulatory correspondence.
  • Maintain and oversee the execution of the integrated global regulatory strategy for a product that aligns cross-functional development plans, regulatory requirements, and commercial objectives.

Requirements

  • Advanced scientific degree (PhD, PharmD, MD, or equivalent)

Skills

  • Advanced scientific degree (PhD, PharmD, MD, or equivalent); MS with significant relevant experience may be considered.
  • Approximately 12+ years of regulatory affairs experience within the biotechnology or pharmaceutical industry.
  • Proven success leading FDA and global Health Authority interactions.
  • Experience leading INDs and major global regulatory submissions.
  • Strong knowledge of global regulatory requirements across all phases of drug development.
  • Excellent communication, negotiation, and cross-functional leadership skills with the ability to influence without direct authority.
  • Experience with targeted oncology therapies and precision medicine.
  • Experience supporting global registrations across multiple regions.
  • #LI-Hybrid #LI-SH1
  • 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

  • $244,000 - $305,000 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

  • Health Authority Leadership
  • Provide strategic oversight for global Health Authority interactions, including FDA, EMA, PMDA, MHRA, and other international agencies.
  • Define the regulatory objectives, messaging, and overall strategy for key Health Authority meetings, including Pre-IND, End-of-Phase, Type B/C, Scientific Advice, and other critical interactions.
  • Interpret Health Authority feedback and translate it into actionable regulatory and development strategies for cross-functional teams.
  • Provide strategic direction for the content and messaging of key regulatory documents to clearly communicate the scientific rationale, development strategy, and benefit-risk profile of assigned programs.
  • Partner closely with Regulatory Operations, Medical Writing, Clinical Development, Biometrics, and CMC to deliver high-quality global submissions.

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.