Director, Regulatory Affairs
: Job Details :

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 professionals in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.The Opportunity:The Director of Regulatory Affairs is accountable for the delivery of regulatory strategy for designated programs at RevMed. They will support programs and drug development teams and ensure delivery of targeted, pragmatic, well-vetted, consistent and actionable regulatory advice. The Director will support policy and process development within regulatory and cross-functionally to define a consistent RevMed approach to regulatory advice and strategy. The Director must have a thorough understanding of and be highly experienced in oncology drug development, applicable regulations, and current health authority thinking, and have strong leadership and relationship-building ability. Deliver sound regulatory strategy to program teamsMotivate, mentor and develop direct reportsEnsure drug development programs are fully resourced for applicable stages of development Anticipate upcoming work; ensure robust and effective regulatory strategy support.Ensure regulatory strategy takes account of competitive developments, expert feedback, and that advice is aligned with company goals and objectivesEnsure regulatory advice, policy and decision-making is consistent across programs and that learnings from one program are fully considered in all other programs.Establish highly collaborative and effective relationships with management colleagues in Clinical Research, Clinical Operations, Regulatory Affairs, Medical Writing, Quality and other functions to ensure cross-functional alignment and team effectiveness.Required Skills, Experience and Education:Degree in life sciences, pharmacy, medicine, or related fields with a minimum of 12 years in the pharmaceutical/biotech industry or relevant work experience and a minimum of 8 years in Regulatory Affairs including regulatory strategy and leadership roles.Demonstrated success in leading regulatory submissions globallyDirect experience with oncology drug development.Experienced in representing Regulatory on cross functional teams and presenting to senior management. Excellent communicator.Excellent planning and organizational skills and the ability to work simultaneously on multiple projects with tight timelines.Preferred Skills:An advanced degree is desirable.Experience with combination studies, multiple expansion cohort, basket or umbrella and master protocols highly preferred.Prior NDA experience is highly preferred.The base salary range for this full-time position is $195,000 to $245,000 for candidates based at our headquarters in Redwood City, CA. The range displayed on each job posting is intended to be the minimum and maximum salary for the position in Redwood City and will be adjusted for the local market a candidate is based. Our salary ranges are determined by role, level, and location. Individual pay is determined by multiple factors, including job-related skills, experience, market dynamics, and relevant education or training.Please note that 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 ...@revmed.com.#LI-Hybrid #LI-SH1