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. The Opportunity: The Senior Director, Molecule Global Regulatory Lead will develop and execute global regulatory strategy for assigned molecule(s) from IND-enabling activities through registration and lifecycle management. This leader will shape innovative and efficient regulatory pathways that enable rapid, science-driven development while positioning assets for long-term success.
In addition to strategic leadership, this role will build and scale fit-for-purpose regulatory processes, frameworks, and capabilities to support portfolio growth. The position reports to the Head of Regulatory Sciences and serves as a key member of the Regulatory leadership team.
Responsibilities
: Global Regulatory Strategy 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.
Requirements
, and commercial objectives. Monitor the evolving global regulatory environment and provide regulatory intelligence that informs development strategy, competitive positioning, and organizational decision-making. 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. Provide strategic guidance for the preparation of briefing documents, meeting requests, responses to agency questions, and regulatory correspondence. Interpret Health Authority feedback and translate it into actionable regulatory and development strategies for cross-functional teams.
Regulatory Submission Leadership Provide strategic oversight for the planning and execution of major regulatory submissions, including INDs, CTAs, amendments, expedited designation requests, marketing applications, and lifecycle submissions.
for the molecule. 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.
Cross-Functional Leadership Represent Regulatory as a core member of cross-functional molecule and development teams.
