Associate Director, Regulatory Science

About this role

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: The Associate Director of Regulatory Science may represent regulatory science on cross-functional teams and provide regulatory advice on clinical development matters. The candidate should have a thorough understanding of oncology drug development, applicable regulations, and current health authority thinking and be able to provide clear and concise feedback, facilitate decision-making and provide effective leadership to ensure successful regulatory outcomes.

Develop, implement, and maintain initiatives, processes, and procedures with a recognition of when to consult departmental senior personnel concerning risks. Plan, prepare, and coordinate regulatory submissions, ensuring high quality and timeline adherence. Utilize a comprehensive knowledge of regulations, regulatory authorities' guidance, and industry practices to support organizational objectives. Able to proactively identify risks and devise mitigation strategies.

Function as a Regulatory Science subject matter expert member of cross-functional teams, including study teams and submission teams. Perform regulatory research to inform business strategy. Assess and communicate risks. Assure that there are no significant interruptions to the business due to regulatory compliance issues. Required Skills, Experience and Education: Bachelor's Degree in a relevant field, an advanced degree is desirable, with a minimum of 9+ years in the pharmaceutical/biotech industry or relevant work experience and a minimum of 5 years in Regulatory Affairs.