Director, Regulatory Affairs

<p>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 Revolutionaries in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.</p> <p><strong>The Opportunity:</strong></p> <ul> <li> <p>Provide clear, effective regulatory strategy as the Regulatory Study Lead for global oncology programs.</p> </li> <li> <p>Anticipate regulatory needs to deliver on program milestones.</p> </li> <li> <p>Develop robust global regulatory strategies that reflect global marketing application filing strategies, expert input, and align with corporate goals to ensure global success.</p> </li> <li> <p>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.</p> </li> </ul> <p><strong>Required Skills, Experience and Education:</strong></p> <ul> <li> <p>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.</p> </li> <li> <p>Proven success in developing and delivering global regulatory strategies and submissions, working independently.</p> </li> <li> <p>Previous experience with NDA and/or global marketing application filings.</p> </li> <li> <p>Previous experience with global ODD annual reports.</p> </li> <li> <p>Demonstrated success in leading health authority interactions and negotiations.</p> </li> <li> <p>Direct experience in oncology drug development including oversight of large, global Phase 3 studies.</p> </li> <li> <p>Skilled at representing Regulatory on cross-functional teams and presenting to senior leadership.</p> </li> <li> <p>Excellent communication, planning, and organizational skills with the ability to manage multiple projects and tight deadlines.<strong> </strong></p> </li> </ul> <p><strong>Preferred Skills:</strong></p> <ul> <li> <p>An advanced degree is desirable.</p> </li> <li> <p>Experience with dose optimization in oncology.</p> </li> <li> <p>Prior NDA experience. </p> <p class="p1"><span style="color: rgb(255, 255, 255);">#LI-Hybrid  #LI-SH1</span></p> </li> </ul><div class="content-pay-transparency"><div class="pay-input"><div class="description"><p>The base pay salary range for this full-time position is listed below. Please note that base pay 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. In addition, some positions may include eligibility to earn commissions/bonus based on company and/or individual performance.</p> <p>Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, field kit benefits, or any other form of compensation and field kit benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.</p> <p>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.</p> <p>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 <a href="https://www.revmed.com/ccpa-notice">CCPA Notice</a> and <a href="https://www.revmed.com/privacy-policy">Privacy Policy</a>. For additional information, please contact <a href="mailto:privacy@revmed.com">privacy@revmed.com</a>.</p></div><div class="title">Base Pay Salary Range</div><div class="pay-range"><span>$211,000</span><span class="divider">—</span><span>$264,000 USD</span></div></div></div><div class="content-conclusion"><hr> <p><em>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.</em><br><em> </em><br><em>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 <strong>@revmed.com</strong> email address.</em><br><em> </em><br><em>If you believe you’ve been contacted by someone impersonating a Revolution Medicines recruiter, please report it to <span style="color: rgb(35, 111, 161);"><strong>careers@revmed.com</strong></span> so we can share these impersonations with our IT team for tracking and awareness.</em></p> <hr> <p> </p></div>