Director, Global CMC Regulatory

Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The Director, Global CMC Regulatory will join other outstanding professionals in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.

Requirements

• Develop and lead execution of effective global CMC regulatory strategies to support initial marketing approvals and lifecycle management of RevMed's product portfolio.
• Oversee the preparation and submission of high-quality CMC dossiers for global marketing authorization applications and post-approval supplements/variations.
• Assess the global regulatory implications of proposed CMC changes and provide proactive, risk-based guidance to optimize implementation and maintain compliance.
• Interpret and apply global CMC regulatory guidance (FDA, EMA, ICH, PMDA, NMPA, MHRA, etc.) to ensure compliant and efficient regulatory pathways.
• Anticipate regulatory risks and proactively develop mitigation strategies aligned with commercial timelines.
• Partner with Regulatory Affairs, technical SMEs, and CROs to ensure alignment of global submission strategies while addressing region-specific CMC requirements and serve as the CMC regulatory representative on global commercial teams to provide guidance that enables efficient global execution.
• Provide strategic leadership, mentorship, and technical guidance to junior team members to foster professional development and team performance.

Benefits

• Competitive cash compensation
• Robust equity awards
• Strong benefits
• Significant learning and development opportunities