Senior Director, Molecule Global Regulatory Lead

Revolution Medicines is a global commercial-state oncology company dedicated to discovering developing and delivering innovative medicines for patients with RAS-addicted cancers. Leveraging its differentiated RAS(ON) tri-complex inhibitor platform the company is advancing a broad integrated portfolio of oral RAS(ON) inhibitors designed to directly target the active cancer-driving state of on rigorous scientific inquiry and a willingness to challenge long-held assumptions Revolution Medicines is committed to changing the trajectory of disease for patients with RAS-addicted cancers worldwide.

Our people are united by a shared way of working: follow the science challenge assumptions act with urgency and hold ourselves to a high standard of rigorall in service of patients.

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.

Primary 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.

Required Skills Experience and Education:

• 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.

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