Senior Associate, Regulatory Affairs

Revolution Medicines seeks a Senior Associate in Regulatory Affairs to support management in operational and submission activities for an oncology-focused company developing RAS inhibitors. The role involves preparing regulatory documents, managing intelligence processes, and maintaining compliance systems while collaborating with global teams.

Responsibilities

• Prepare, review, and coordinate regulatory submission documents and global CTA filings
• Establish and manage regulatory intelligence newsletter including content and vendor management
• Identify and lead implementation of improvements to regulatory workflows and processes
• Maintain regulatory information management systems and electronic repositories for accuracy
• Collaborate with global filing teams, business excellence group, and external partners

Requirements

• Bachelor's degree in relevant scientific or regulatory field
• Minimum two years regulatory affairs experience at pharmaceutical or biologics company
• Knowledge of FDA regulations, guidance documents, and ICH guidelines
• Proficiency with Windows, MS Office, Adobe Acrobat, and document management systems
• Commitment to advancing regulatory knowledge through ongoing education