Director, Regulatory Operations, Submissions

Revolution Medicines - San Francisco Bay Area

Hiring: Director, Regulatory Operations, Submissions Company: Revolution Medicines Location: San Francisco Bay Area Job Posted Time: 2026-09-10 11:48:19 Employment Type: Full-time About the job Experience: •12+ years of experience in the biotechnology, pharmaceutical, or medical device industry. Required Skills: •Lead and be accountable for global regulatory submission execution across all application types, supporting increasing submission volume, portfolio expansion, and organizational growth. •Provide strategic and operational leadership within Regulatory Operations, contributing to functional direction, capability planning, and continuous improvement while maintaining strong executional accountability. •Translate regulatory strategies into executable submission plans, timelines, resource requirements, and operational approaches. •Provide oversight for the planning, preparation, publishing, submission, and archiving of high-quality, compliant global regulatory dossiers. •Lead, mentor, and develop a submissions-focused team, fostering accountability, collaboration, operational excellence, and continuous improvement. •Oversee external publishing vendors to ensure timely, compliant, high-quality execution and effective use of external resources. •Define, own, and maintain submission-related standard operating procedures (SOPs), work instructions, job aids, standards, policies, and best practices to drive consistent execution across programs and regions. •Drive continuous improvement of submission processes to reduce cycle times, increase predictability, improve quality, and support organizational scale. 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!