Hiring: Senior Associate, Regulatory Affairs Company: Revolution Medicines Location: San Francisco Bay Area Job Posted Time: 2026-09-10 11:48:19 Employment Type: Full-time Target Skills & Keywords : Microsoft Excel, Microsoft Office About the job Experience: •4+ years' experience in a Regulatory Affairs department at a drug or biologics company. Required Skills: •The Senior Associate Regulatory Affairs will support Senior Regulatory Affairs management in day-to-day operational aspect of the department and will support interactions with global regulatory authorities. •Represent Regulatory Affairs on project teams and closely collaborate with multidisciplinary teams to identify submission requirements, coordinate the content and development process (planning, creation, review, and approval) of selected regulatory documentation for inclusion in submissions to global health authorities. •Compile regulatory submissions that meet ICH or FDA requirements, other local or regional regulatory requirements, as applicable, and company policies and procedures. •Prepare and manage routine submissions and related activities. Define and manage detailed timelines to ensure timely delivery of high-quality, compliant, accurate and complete regulatory submissions. •Assist in the development and implementation of SOPs and systems to track and manage product-associated events. •Investigate and evaluate regulatory history/background of class, disease/therapeutic/diagnostic context to assist in assessment of regulatory implications for development and approval. Assist in the development of regulatory strategy and update strategy based upon regulatory changes. •Stay abreast of changes in the regulatory environment and guidelines (e.g., FDA, ICH) in areas relevant to company projects. •Interface directly with manager on acquisition and development of required regulatory skills and knowledge. Qualifications: •Bachelor’s degree in a relevant field. •Willing to advance my knowledge of regulatory practice through classes, certifications, webinars. Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!