Senior Manager, 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> <p>The Senior Manager of Regulatory Affairs will provide project teams with regulatory advice, manage, and coordinate various Regulatory Affairs activities within and between departments, and obtain and maintain National Health Authority approvals for investigational products. The position may also undertake regulatory intelligence and research supporting company decision-making.</p> <p><strong>Specifically, you will be responsible for:</strong></p> <ul> <li> <p>Manage planning, preparation, coordination, and submission of regulatory documents to global National Health Authorities. Such submissions may include Clinical, Preclinical, or CMC content.</p> </li> <li> <p>Correspond and collaborate with RevMed colleagues and departments to achieve alignment.</p> </li> <li> <p>Function as a Regulatory Affairs subject matter expert member of cross-functional teams, including study teams and submission teams.</p> </li> <li> <p>Perform regulatory research to inform business strategy. Assess and communicate risks.</p> </li> <li> <p>Assure that there are no significant interruptions to the business due to regulatory compliance issues.</p> </li> <li> <p>Collaborates across the organization at all levels, across functional groups, and with executive management.</p> </li> <li> <p>Develop regulatory strategies to inform associated budgets, tools, and specialized support necessary for efficient operations.</p> </li> </ul> <p><strong>Required Experience, Skills, and Education:</strong></p> <ul> <li> <p>Bachelor's Degree in a relevant field and at least 5 years of direct Regulatory experience.</p> </li> <li> <p>Strong working knowledge of US FDA Pharmaceutical regulations and guidance.</p> </li> <li> <p>Knowledge of EU EMA Pharmaceutical regulations and guidance preferred.</p> </li> <li> <p>Proven track record of successful submissions within a regulatory environment.</p> </li> <li> <p>Exceptionally strong team player with excellent interpersonal and communication skills.</p> </li> <li> <p>Detail-oriented with strong organizational skills and high-quality standards.</p> </li> </ul> <p><strong> </strong><strong>Preferred Skills:</strong></p> <ul> <li> <p>Direct experience with oncology drug development highly preferred.</p> </li> <li> <p>Experience with combination studies, multiple expansion cohort, basket, or umbrella master protocols highly preferred.</p> </li> <li> <p>Direct experience with FDA expedited programs highly preferred.</p> </li> </ul> <p><span style="color: rgb(255, 255, 255);">#LI-Hybrid  #LI-SH1</span></p><div class="content-pay-transparency"><div class="pay-input"><div class="description"><p>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.</p> <p>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.</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>$164,000</span><span class="divider">—</span><span>$205,000 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>