Director, Regulatory Operations

Revolution Medicines•Redwood City, CA

3h•Onsite

About The Position

Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) Inhibitors designed to suppress diverse oncogenic variants of RAS proteins, and RAS Companion Inhibitors for use in combination treatment strategies. As a new member of the Revolution Medicines team, you will join other outstanding Revolutionaries in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway. The Opportunity: The Director of Regulatory Operations will lead and be accountable for global regulatory submissions execution, submission-related policies, and end-to-end regulatory processes that support growth and increased portfolio complexity. This position offers the opportunity to strengthen and mature submissions operations through clear process ownership, procedural rigor, and operational excellence. Reporting to the Head of Regulatory Operations, this role serves as a strategic leader within Regulatory Operations, contributing to functional direction, capability planning, and continuous improvement while maintaining strong executional accountability. Success in this role requires the ability to execute while building, work effectively in a dynamic and highly collaborative environment, and remain flexible and adaptive as priorities evolve.

Requirements

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.

Nice To Haves

Seasoned people manager.
Adept in regulatory publishing; capable of serving as a backup publisher.
Proficient in Smartsheet for project tracking and collaboration.

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.