Revolution Medicines · 3 days ago
Associate Director, Regulatory Operations
San Francisco Bay Area
Full-time
Onsite
Lead/Staff, Director/Executive
$180K/yr - $225K/yr
8+ years expRevolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies. The Associate Director, Regulatory Operations will manage and execute regulatory submission activities to support the company’s growing pipeline and ensure compliance with global health authority requirements.
Health CareLife ScienceMedical
Responsibilities
Oversee the planning, preparation, publishing, submission, and archiving of regulatory dossiers in eCTD format for multiple FDA applications and global submissions
Manage submission production and quality control (QC) processes, ensuring compliance with global regulatory requirements and internal standards
Provide technical expertise in eCTD publishing tools and platforms (e.g., Veeva Vault RIM) to enable efficient and compliant submission execution
Proactively manage publishing timelines from request through archive, anticipating potential issues, escalating risks early, and collaborating with cross-functional teams to adapt plans as needed
Support the implementation, optimization, and maintenance of regulatory systems, tools, and technologies to improve submission efficiency and scalability
Partner with cross-functional stakeholders to ensure regulatory systems and workflows are well-documented, scalable, and aligned with business needs
Drive the development and continuous improvement of SOPs, templates, style guides, and document standards to support compliance and operational efficiency
Stay informed on emerging tools, technologies, and industry best practices, identifying opportunities to enhance submission operations and supporting the evaluation and adoption of innovative solutions where appropriate
Collaborate with internal stakeholders across clinical, CMC, quality, nonclinical, and regulatory strategy teams to coordinate the creation, review, and approval of regulatory submission documents
Manage relationships with publishing vendors and consultants, ensuring appropriate resource allocation and adherence to quality and delivery expectations
Provide training and guidance to internal teams on publishing procedures, tools, and best practices to ensure submission readiness
Communicate complex regulatory and operational issues clearly, providing solutions that balance compliance with the demands of growth and scale
Conduct gap analyses of regulatory operations policies, procedures, and SOPs, driving initiatives to enhance departmental efficiency and compliance
Maintain current knowledge of regulatory requirements, evolving eCTD guidance, and the broader regulatory operations landscape, providing interpretation and guidance to internal stakeholders
Qualification
Required
Bachelor's degree in a life science, technical, or related field with 8+ years of Regulatory Operations and publishing experience in the biopharmaceutical industry; advanced degree preferred
Expert-level proficiency in Microsoft Word, Adobe Acrobat Professional, Toolbox, and StartingPoint
Thorough understanding of eCTD publishing standards, submission formatting, transmission, and archiving regulations and guidelines
Experience preparing and submitting regulatory dossiers to multiple global Health Authorities; oncology experience is a plus
Demonstrated ability to manage and prioritize multiple FDA applications and submissions with overlapping deadlines while maintaining accuracy and compliance
Ability to anticipate risks and proactively identify solutions to potential publishing and submission challenges
Strong organizational skills with high attention to detail and the ability to work independently in a dynamic, fast-paced environment
Proven success collaborating with cross-functional teams and external vendors to deliver high-quality, compliant submissions
Excellent interpersonal and communication (written and verbal) skills; able to work effectively across multiple groups, maintaining professionalism, diplomacy, and a positive approach
Preferred
Some experience with people management, such as mentoring, training, or overseeing vendors and consultants
Proficiency with Veeva Vault RIM or similar regulatory information management systems
Experience using Smartsheet or equivalent project management tools
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
2025-12-18
2025-12-18
Company data provided by crunchbase