Senior Director, Molecule Global Regulatory Lead

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, including 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, currently in clinical development.

About the role

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. The role involves building and scaling 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.
  • 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.
  • 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.
  • Ensure submission strategies align with the overall global regulatory strategy, development objectives, and applicable regulatory requirements 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.
  • Provide strategic regulatory guidance for clinical development plans, protocol design, indication expansion, and lifecycle opportunities.
  • Partner closely with Clinical Development, Clinical Operations, Safety, Nonclinical, CMC, Biometrics, Medical Writing, Program Management, and Commercial to ensure regulatory strategy is fully integrated into program execution.
  • Communicate regulatory strategy, risks, tradeoffs, and recommendations to senior leadership and governance committees.
• Leadership & Collaboration
  • Foster a collaborative, solutions-oriented approach across cross-functional teams.
  • Manage regulatory leads and support teams and contribute to development of regulatory capabilities across the organization.
  • Champion regulatory excellence, continuous improvement, and strategic thinking throughout product development.

Requirements

• 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.
• Demonstrated experience serving as the Global Regulatory Lead for oncology development programs.
• Significant experience developing global regulatory strategies from early development through registration.
• 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.

Preferred Skills

• Experience with targeted oncology therapies and precision medicine.
• Experience supporting accelerated approval pathways, including Fast Track, Breakthrough Therapy, Priority Review, Sakigake, PRIME, or comparable programs.
• Experience supporting global registrations across multiple regions.

Pay

Base pay salary range for this full-time position for candidates working onsite at our headquarters in Redwood City, CA: $244,000 - $305,000 USD. The range displayed is intended for an individual working onsite in Redwood City and will be adjusted for the local market a candidate is based in. Base pay salary is determined by role, level, location, job-related skills, experience, market dynamics, and relevant education or training.

Benefits

Competitive cash compensation, robust equity awards, strong benefits, and significant learning and development opportunities.