Revolution Medicines · 1 day ago
Director, Regulatory Operations
San Francisco Bay Area
Full-time
Hybrid
Director/Executive
$211K/yr - $264K/yr
15+ years expRevolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies for RAS-addicted cancers. The Director of Regulatory Operations will lead global regulatory submissions, enhance operational processes, and ensure compliance while collaborating with cross-functional teams.
Health CareLife ScienceMedical
Responsibilities
Provide operational leadership and accountability for global regulatory submissions across all application types, with strategic input to support increasing submission volume, portfolio expansion, and organizational growth
Advance cross-functional initiatives that enhance the department’s effectiveness and support broader Regulatory objectives
Translate regulatory strategies into executable submission plans, timelines, and resource models
Provide oversight for teams responsible for planning, preparing, publishing, submitting, and archiving global regulatory dossiers
Lead and mentor a submissions-focused team and oversee external vendors to ensure timely, compliant, and high-quality regulatory publishing
Communicate complex issues clearly, providing solutions that balance compliance with the demands of scale
Drive the development, optimization, and implementation of procedures, training, and documentation to support compliant and efficient submission operations
Define, own, and maintain regulatory submissions–related SOPs, work instructions, job aids, standards, policies, and best practices to ensure consistent execution across programs and regions
Drive continuous improvement of submission processes to reduce cycle times, increase predictability, and improve quality
Ensure alignment of submission processes with Quality systems and inspection-readiness expectations
Partner closely with Medical Writing, Regulatory Affairs, Quality, Clinical Operations, and external partners to ensure seamless handoffs and role clarity across the submission lifecycle
Provide clear operational guidance and training to cross-functional contributors involved in submissions
Partner with the Regulatory Systems lead by providing business requirements, operational input, and process alignment to ensure systems effectively support submissions execution, without serving as system owner or administrator
Qualification
Required
Bachelor's degree in a life science, or related field with 15+ years of experience in the biotechnology, pharmaceutical, or medical device industry, with at least 8 years focused on Regulatory Affairs/Operations and Veeva RIM systems (administration, configuration, and optimization)
Proven leadership in developing and executing regulatory operations strategy within global biotech or biopharma organizations
Deep expertise in submission planning, global regulatory frameworks, eCTD standards, and Health Authority requirements
Strong understanding of regulatory systems from a business process and end-user perspective
Strong project management skills, with the ability to oversee multiple priorities and deliver results in a dynamic environment
Clear and persuasive communicator across technical and business stakeholders
Effective collaborator with the ability to influence and align cross-functional teams
Strategic thinker with a practical problem-solving mindset and long-term business orientation
Committed to developing high-performing teams and fostering a culture of accountability and continuous improvement
Experience leading process improvement initiatives in a compliance-focused environment
Preferred
Seasoned people manager
Adept in regulatory publishing; capable of serving as a backup publisher
Proficient in Smartsheet for project tracking and collaboration
Benefits
Competitive cash compensation
Robust equity awards
Strong benefits
Significant learning and development opportunities
Company
Revolution Medicines
Revolution Medicines is an innovative and dynamic organization of expert biologists, chemists, pharmacologists, clinical scientists.
501-1000 employees
H1B Sponsorship
Revolution Medicines has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (13)
2024 (18)
2023 (15)
2022 (8)
2021 (1)
2020 (2)
Funding
Current Stage
Public CompanyTotal Funding
$2.25BKey Investors
Royalty PharmaBoxer CapitalNextech Invest
2025-06-24Post Ipo Debt· $250M
2024-12-02Post Ipo Equity· $750M
2023-03-02Post Ipo Equity· $323.6M
Leadership Team
Luan Wilfong
Chief Human Resources Officer
Steve Kelsey
President
Recent News
Genetic Engineering News
2026-02-02
Pharmaceutical Technology
2026-01-13
Company data provided by crunchbase