Associate Director, Regulatory Operations

Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The Associate Director, Regulatory Operations will oversee the planning, preparation, publishing, submission, and archiving of regulatory dossiers in eCTD format for multiple FDA applications and global submissions.

Requirements

• Bachelor’s degree in a life science, technical, or related field with 8+ years of Regulatory Operations and publishing experience in the biopharmaceutical industry
• Expert-level proficiency in Microsoft Word, Adobe Acrobat Professional, Toolbox, and StartingPoint.
• Thorough understanding of eCTD publishing standards, submission formatting, transmission, and archiving regulations and guidelines.
• Experience preparing and submitting regulatory dossiers to multiple global Health Authorities; oncology experience is a plus.
• Demonstrated ability to manage and prioritize multiple FDA applications and submissions with overlapping deadlines while maintaining accuracy and compliance.
• Strong organizational skills with high attention to detail and the ability to work independently in a dynamic, fast-paced environment.
• Proven success collaborating with cross-functional teams and external vendors to deliver high-quality, compliant submissions.
• Excellent interpersonal and communication (written and verbal) skills; able to work effectively across multiple groups, maintaining professionalism, diplomacy, and a positive approach.

Benefits

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