Senior Director, Regulatory Operations - REVOLUTION Medicines

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 scientists in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.

The Opportunity:

The Senior Director of Regulatory Operations, reporting to the Vice President of Regulatory Affairs, will lead and grow a highly active Regulatory Operations function. The Senior Director of Regulatory Operations will work with internal and contract resources as needed to provide regulatory operations services to several active drug development programs and build capacity and processes to support future major submissions. 

Specifically, you will be responsible for:

• Build and lead a highly effective, highly collaborative Regulatory Operations function that serves multiple global programs simultaneously.

• Work closely with Regulatory Affairs, Medical Writing, cross-functional stakeholders and project teams to provide strategic and operational oversight for the planning, preparation, tracking, and timely submission of health authority applications and updates to global health authorities (e.g., IND, NDA, BLA, MAA, etc.)

• Oversee/manage submission projects across all submission types throughout the product lifecycle at any level of complexity.

• Provide input and/or guidance on current technical aspects of submission requirements, working with internal stakeholders and vendors/CROs to ensure submission compliance requirements are met.

• Ensure standard procedures for publishing, submission, archiving, and metric tracking are in place and are followed.

• Support consistent use of templates and style guides for regulatory submissions with input from Regulatory Affairs, Medical Writing and other stakeholders.

• Monitor and assess business trends, pending regulations or guidance documents, and emerging technologies for potential regulatory operations impact, develop action plans and business tools accordingly.

Required Experience, Skills, and Education:

• A B.S., or advanced degree, in the sciences with 10+ years of regulatory operations experience within the pharmaceutical or biotechnology industry, 5+ years in a senior or leadership role

• Regulatory submissions experience with large applications such as NDA, MAA, etc., ideally experienced in all phases of product development, pre-and post-marketing.

• Positive attitude, flexible and able to negotiate timelines with our stakeholders. Collaborative, team approach, ability to develop and maintain strong business relationships.

Revolution Medicines currently requires that all personnel and visitors to its offices be fully vaccinated against COVID-19. This role will require that the employee meet with company employees and work from the company’s offices. Given that these essential functions of the role must be performed on-site, this position requires full COVID-19 vaccination, subject to applicable law.

The expected salary range for this role is $235,000 to $281,000. An individual’s position within the range may be influenced by multiple factors, including skills and experience in role, overall performance, individual impact and contributions, tenure, and market dynamics. Base salary 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 privacy@revmed.com.