Director, Regulatory Operations, Submissions

Regulatory Jobs; Redwood City (CA); On-site; USD 211,000 - 264,000; Full time

Job summary

Revolution Medicines is seeking a senior Regulatory Operations leader to drive global submission execution and strategy. You will lead a submissions-focused team, partner with Regulatory Affairs, Medical Writing, Quality, and Clinical Operations, and oversee external publishing vendors to ensure high-quality, timely dossiers.

The role requires a 12+ year background in regulatory operations within biotech/pharma, strong leadership, and expertise in eCTD standards, RIM systems, and submission

Qualifications

• Bachelor’s degree in a life science; 12+ years in biotech/pharma/medical device.
• Seasoned people manager with proven leadership of high-performing teams.
• Global submission planning and eCTD/regulatory framework expertise.
• Proven ability to drive submission quality, process excellence, and timelines.
• Proficiency with DocuBridge and Veeva RIM for regulatory publishing.

Responsibilities

• Lead and be accountable for global regulatory submission execution across applications.
• Provide strategic and operational leadership within Regulatory Operations.
• Translate regulatory strategies into executable submission plans and timelines.
• Oversee planning, publishing, submission, and archiving of global dossiers.
• Lead, mentor, and develop a submissions-focused team.
• Oversee external publishing vendors to ensure quality and timeliness.
• Define and maintain submission SOPs, work instructions, and policies.
• Drive continuous improvement of submission processes for scale.
• Ensure alignment with Quality systems and regulatory requirements.
• Partner with cross-functional stakeholders for coordinated execution.
• Provide operational training to contributors involved in submissions.
• Communicate risks and issues with practical solutions.
• Advance cross-functional initiatives to improve regulatory effectiveness.
• Collaborate with Regulatory Systems to support submission execution.

Skills

Leadership

Global submissions

Regulatory operations

eCTD expertise

RIM proficiency

Project management

Cross-functional collaboration

Strategic thinking

Communication

Education

Bachelor’s degree in life science

Tools

DocuBridge

Veeva RIM

Smartsheet

Job description

Revolution Medicines is a global, commercial-state oncology company dedicated to discovering, developing and delivering innovative medicines for patients with RAS-addicted cancers. Leveraging its differentiated RAS(ON) tri-complex inhibitor platform, the company is advancing a broad, integrated portfolio of oral RAS(ON) inhibitors designed to directly target the active, cancer-driving state of RAS.Founded on rigorous scientific inquiry and a willingness to challenge long-held assumptions, Revolution Medicines is committed to changing the trajectory of disease for patients with RAS-addicted cancers worldwide.

Our people are united by a shared way of working: follow the science, challenge assumptions, act with urgency and hold ourselves to a high standard of rigor—all in service of patients.

The Opportunity:

• 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.
• Ensure submission processes and practices align with Quality systems, regulatory requirements, and inspection-readiness expectations.
• Partner closely with Regulatory Affairs, Medical Writing, Quality, Clinical Operations, and other cross-functional stakeholders to establish clear roles, effective handoffs, and coordinated execution across the submission lifecycle.
• Provide operational guidance and training to cross-functional contributors involved in regulatory submissions.
• Communicate complex submission issues and risks clearly and proactively, developing practical solutions that balance compliance, business needs, and the demands of a growing portfolio.
• Advance cross-functional initiatives that improve Regulatory effectiveness and support broader departmental objectives.
• Partner with the Regulatory Systems lead to define business requirements, provide operational input, and ensure regulatory systems and processes effectively support submission execution.

Required Skills, Experience and Education:

• Bachelor’s degree in a life science, or related field with 12+ years of experience in the biotechnology, pharmaceutical, or medical device industry.
• Seasoned people manager with demonstrated experience leading and developing high-performing teams.
• Proven leadership in developing and executing Regulatory Operations strategies within global biotechnology or biopharmaceutical organizations.
• Deep expertise in global submission planning and execution, electronic Common Technical Document (eCTD) standards, regulatory frameworks, and Health Authority requirements.
• Demonstrated ability to contribute to operational strategy while maintaining strong accountability for submission execution, quality, and process excellence.
• Strong understanding of regulatory systems from a submissions operations, business-process, and end-user perspective.
• Experience leading process improvement initiatives within a regulated, compliance-focused environment.
• Strong project and operational management skills, with the ability to manage multiple priorities and deliver results in a dynamic environment.
• Clear and persuasive communicator with the ability to translate complex operational issues for technical, cross-functional, and senior stakeholders.
• Effective collaborator with demonstrated ability to influence and align cross-functional teams.
• Strategic thinker with a practical problem-solving mindset and ability to balance immediate execution needs with longer-term organizational scalability.
• Proficiency with DocuBridge and Veeva Regulatory Information Management (RIM).

Preferred Skills:

• Hands-on regulatory publishing experience with the technical capability to provide publishing support when needed.
• Experience using Smartsheet for submission planning, project tracking, and collaboration.
• Eperience supporting or managing a global regulatory portfolio.

#LI-JC1 #LI-Hybrid

The base pay salary range for this full-time position for candidates working onsite at our headquarters in Redwood City, CA is listed below. The range displayed on each job posting is intended to be the base pay salary range for an individual working onsite in Redwood City and will be adjusted for the local market a candidate is based in. Our base pay salary ranges are determined by role, level, and location. Individual base pay salary is determined by multiple factors, including job-related skills, experience, market dynamics, and relevant education or training.

Please note that base pay salary range is one part of the overall total rewards program at RevMed, which includes competitive cash compensation, robust equity awards, strong benefits, and significant learning and development opportunities.

Revolution Medicines is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital status, medical condition, and veteran status.

Revolution Medicines takes protection and security of personal data very seriously and respects your right to privacy while using our website and when contacting us by email or phone. We will only collect, process and use any personal data that you provide to us in accordance with our CCPA Notice and Privacy Policy. For additional information, please contact [e-mail].

Base Pay Salary Range

$211,000—$264,000 USD