Hiring: Associate Director, Global Regulatory Affairs Project Management Company: Revolution Medicines Location: San Francisco Bay Area Job Posted Time: 2026-09-10 11:48:19 Employment Type: Full-time Target Skills & Keywords : Project Management About the job Experience: •12+ years of pharma / biotech industry experience, including 6-8+ years of regulatory project management experience. Hands-on U.S. drug marketing application experience required. Required Skills: •The ideal candidate will have an in-depth understanding of oncology drug development and demonstrated hands-on regulatory project management experience supporting early- and late-stage registrational programs, including the execution of global new drug marketing applications, in alignment with corporate objectives. •Project manages regulatory submissions from initiation through submission, supporting the definition of scope, timelines, prioritization, resource needs, and key deliverables. •Develop, maintain, and track comprehensive submission timelines for INDs / CTAs, NDAs / MAAs, amendments, agency interactions, and other key global regulatory activities. •Partner with Global and Regional Regulatory Science Leads to advance global regulatory strategies for assigned molecules across indications. •Facilitate Global Regulatory Teams and meetings to ensure coordinated development and execution of high-quality, timely global regulatory deliverables at the study level •Partner with Global Filing Leads on planning, resourcing, and execution of new drug marketing applications for global agency submissions, interactions, and approvals. •Coordinate with global partners to maintain consistent regulatory program plans, ensuring alignment, compliance, and continuity across regions. •Proactively identify operational risks, gaps, and bottlenecks; propose and implement solutions, including process improvements and outsourcing strategies, as appropriate. Qualifications: •Bachelor’s degree in life sciences or related discipline; advanced degree preferred. Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!