Senior Associate, Regulatory Affairs

Revolution Medicines•Redwood City, CA

4d•Hybrid

About The Position

Revolution Medicines is a global, commercial-stage 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 Senior Associate Regulatory Affairs will support Senior Regulatory Affairs management in the day-to-day operational aspects of the department and will support interactions with global regulatory authorities.

Requirements

Bachelor’s degree in a relevant field.
Two or more years prior experience in a Regulatory Affairs department at a drug or biologics company.
Some familiarity with regulatory requirements for development of drug and biological products, including FDA regulations and guidance, and ICH guidelines.
Willing to advance knowledge of regulatory practice through classes, certifications, webinars.
Technical expertise with Windows, MS Office (Outlook, Word, Excel), Adobe Acrobat software systems, and experience working in an electronic document management system.

Nice To Haves

Experience in oncology drug development.
Experience with supporting the preparation and submission of large complex regulatory submissions.

Responsibilities

Provide support for the preparation, quality review, and coordination of regulatory submission documents and global CTA submissions across programs.
Establish and manage the Regulatory Intelligence newsletter, including content development, sustainable distribution processes, vendor management, and continuous process improvements.
Identify opportunities to improve Regulatory Science processes/workflows and independently lead or assist implementation of approved solutions.
Support the maintenance of Regulatory Information Management (RIM) systems and electronic document repositories to ensure data accuracy and compliance.
Work closely with Global Filing Team, Business Excellence group, and external vendors.