Manager, Regulatory Affairs at Revolution Medicines

United States

$168.064k - $178k

Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) inhibitors designed to suppress diverse oncogenic variants of RAS proteins. The company’s RAS(ON) inhibitors daraxonrasib (RMC-6236), a RAS(ON) multi-selective inhibitor; elironrasib (RMC-6291), a RAS(ON) G12C-selective inhibitor; zoldonrasib (RMC-9805), a RAS(ON) G12D-selective inhibitor; and RMC-5127, a RAS(ON) G12V-selective inhibitor, are currently in clinical development. As a new member of the Revolution Medicines team, you will join other outstanding professionals in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway. The Opportunity: Manage planning, preparation (including authoring when appropriate), coordination, and submission of regulatory documents to global National Health Authorities that meet ICH and FDA standards, and other local or regional regulatory requirements. Such submissions may include Clinical and Preclinical content. Assist and keep detailed timelines for regulatory activities and submissions. Perform regulatory research to assess regulatory implications and inform business strategy for drug development and approval. Assess and communicate risks. Ensure that there are no significant interruptions to the business due to regulatory compliance issues. Correspond and collaborate across the organization at all levels, across functional groups, and with executive management. Support NDA filing activities and assist with developing regulatory process supporting the filing. Prepare and manage routine submissions and related activities. Develop regulatory strategies to inform associated budgets, tools and specialized support necessary for efficient operations. Stay abreast of changes in the regulatory environment and guidelines (e.g., FDA, ICH) in areas relevant to company projects. Required Skills, Experience and Education: Bachelor’s degree or equivalent in Regulatory Science or related degree in Life Science or Health Science fields. Three (3) years of experience in Regulatory Affairs department at a drug or biologics company. Employer will accept a Master's degree or equivalent in Regulatory Science or related degree in Life Science or Health Science fields and one (1) year of experience in Regulatory Affairs department at a drug or biologics company. Work experience to include: Manage the preparation and submission of initial IND (Investigational New Drug) application and subsequent amendments; Manage the development of regulatory submissions in eCTD (electronic Common Technical Document) format; Interpret and apply FDA (Food and Drug Administration), ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use), EMA (European Medicines Agency), or PMDA (Pharmaceuticals and Medical Devices Agency) regulations to oncology drug development; Manage global regulatory health authority filings and subsequent amendments. Successful completion of background checks and employment history verification required. 100% remote position reporting to Revolution Medicines, Inc. in Redwood City, CA. Candidate may live anywhere in the continental U.S. The base pay salary range for this full-time position for candidates working onsite at our headquarters in Redwood City, CA is listed below. The range displayed on each job posting is intended to be the base pay salary range for an individual working onsite in Redwood City and will be adjusted for the local market a candidate is based in. Our base pay salary ranges are determined by role, level, and location. Individual base pay salary is determined by multiple factors, including job-related skills, experience, market dynamics, and relevant education or training. Please note that base pay salary range 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. Base Pay Salary Range $168,064—$178,000 USD We are aware of recent recruitment scams in which individuals or organizations falsely represent themselves as being affiliated with Revolution Medicines. These scams may appear as false job advertisements or unsolicited contacts through communication or chat platforms, email, phone, or text message. Please note that Revolution Medicines does not extend unsolicited employment offers and will never ask candidates to provide financial information, purchase equipment, or pay fees as part of the hiring process. All legitimate communication from Revolution Medicines will come from an official @revmed.com email address. If you believe you’ve been contacted by someone impersonating a Revolution Medicines recruiter, please report it to careers@revmed.com so we can share these impersonations with our IT team for tracking and awareness.