Associate Director, Regulatory Operations

Revolution Medicines

Redwood City, United States
Base: $186,000—$233,000 usd; bonus/equity: not spe...
On-site
Ectd publishing tools and platforms
Regulatory submission activities
Regulatory dossier management
Revolution Medicines is seeking an Associate Director of Regulatory Operations to oversee regulatory submissions for its oncology pipeline. The role emphasizes a strong background in eCTD publishing and regulatory compliance, with a focus on cross-functional collaboration

Job Summary

  • Manage and execute regulatory submission activities to support the company’s growing pipeline and portfolio, ensuring timely, accurate, and compliant submissions to global Health Authorities.
  • Oversee the planning, preparation, publishing, submission, and archiving of regulatory dossiers in eCTD format for multiple FDA applications and global submissions.
  • Partner with cross-functional stakeholders to ensure regulatory systems and workflows are well-documented, scalable, and aligned with business needs.

Matching Summary

Match Score: 85

Revolution Medicines is seeking an Associate Director of Regulatory Operations to oversee regulatory submissions for its oncology pipeline. The role emphasizes a strong background in eCTD publishing and regulatory compliance, with a focus on cross-functional collaboration.

Salary

Base: $186,000—$233,000 USD; Bonus/Equity: Not specified; Benefits: Not specified

Skills & Requirements

Must-have

  • eCTD publishing tools and platforms
  • regulatory submission activities
  • regulatory dossier management
  • cross-functional team collaboration
  • vendor and consultant management

Nice-to-have

  • people management experience
  • Smartsheet or equivalent tools
  • oncology experience is a plus

Key Requirements

  • 8+ years of Regulatory Operations and publishing experience
  • Bachelor’s degree in a life science, technical, or related field
  • Expert-level proficiency in Microsoft Word, Adobe Acrobat Professional, Toolbox, and StartingPoint
  • Thorough understanding of eCTD publishing standards

Work Rights

Not specified

Tailored Resume

Cover Letter