Senior Director, Regulatory Operations

<div class="content-intro"><p><strong><span data-contrast="auto">About Us</span></strong><span data-ccp-props="{}">&nbsp;</span></p> <div data-olk-copy-source="MessageBody">Kardigan is a heart health company working to make cardiovascular disease preventable, curable and no longer the leading cause of death in the world.<br><br></div> <div>It is Kardigan’s mission to develop multiple targeted treatments in parallel that bring people with cardiovascular diseases to the cures they deserve.</div> <div>&nbsp;</div> <div>Led by Tassos Gianakakos, Jay Edelberg, <span data-olk-copy-source="MessageBody">M.D., Ph.D.,</span> and Bob McDowell, Ph.D., Kardigan’s co-founders have reunited after leading MyoKardia to discover and develop mavacamten, the first cardiac myosin inhibitor, resulting in an acquisition by Bristol Myers Squibb in 2020.</div> <div>&nbsp;</div> <div>We have a cutting-edge discovery and translational research platform, a pipeline of late-stage candidates, and an industry-leading team that is driven to improve the lives of patients.</div> <div>&nbsp;</div> <div>At Kardigan, we are motivated by our values which guide how we work, interact, and achieve our goals. <strong>Driven by patients and their families</strong>, we are deeply committed to improving the lives of patients and prioritizing their needs above all else. We believe in <strong>being authentic</strong>—leading with truth to bring out the best in others by creating an environment where every person knows they will be fully accepted. With an <strong>eagerness to learn</strong>, we encourage the highest levels of curiosity and are open to changing our minds. We are committed to <strong>winning as a team</strong> with urgency, excellence, and intention, and support each other no matter what role we play or where we sit. Lastly, we strive to <strong>enable the impossible</strong> because patients are counting on us. We are not afraid to take risks to unlock innovation and advance scientific discoveries.</div> <div>&nbsp;</div> <div>These values are the foundation of our work, empowering us to make a real difference, every day.</div> <div>&nbsp;</div> <div>&nbsp;</div></div><p><strong>Position Title: Senior Director, Regulatory Operations</strong></p> <p><strong>Department: </strong>Regulatory</p> <p><strong>Reports To</strong>: SVP, Head of Regulatory</p> <p><strong>Location:</strong> South San Francisco, CA (preferred) or Princeton, NJ – On site 4 days a week (Mon to Thurs)</p> <p>&nbsp;</p> <p><strong>Job Overview</strong></p> <p>Kardigan is seeking an experienced Senior Director, Regulatory Operations. Reporting directly to the SVP of Regulatory, the Senior Director will oversee global Regulatory Operations across Kardigan’s portfolio.</p> <p>This role is responsible for end-to-end management of global regulatory submissions, ensuring timely and compliant publishing, electronic submission and archival. The Senior Director will partner closely with Regulatory and cross-functional team members to deliver high quality, inspection ready submissions aligned with corporate objectives. This role will ensure or establish best practices for Regulatory Operations.</p> <p><strong>&nbsp;</strong></p> <p><strong>Key Responsibilities</strong></p> <p><strong>Regulatory Submission Planning, Strategy &amp; Execution</strong></p> <ul> <li>Oversee all regulatory submission types (eg, IND, CTA, NDA, MAA, and amendments) across Kardigan’s portfolio.</li> <li>Manage planning, publishing, electronic submission, and archival of regulatory submissions.</li> <li>Establish clear lines of communication with stakeholders to align regulatory plans that maximize efficiency and quality of regulatory submissions.</li> </ul> <p><strong>Regulatory Operations Leadership &amp; Team Management</strong></p> <ul> <li>Build, mentor, and manage a high-performing Regulatory Operations team, including contractors and vendors, to achieve overall corporate objectives.</li> <li>Manage external vendors, CROs, and consultants for performance and budget.</li> <li>Set clear goals and expectations, supporting continuous improvement and accountability.</li> <li>Support cross-functional employee on-boarding and training by providing technical support to stakeholders and project team members as needed.</li> <li>Support Regulatory budgeting and forecasting activities, including review of expenditures for activities related to vendor contracts.</li> </ul> <p><strong>Systems, Tools &amp; Process Optimization</strong></p> <ul> <li>Maintain and enhance regulatory systems and tools (RIM, publishing, document management, templates and relevant style guides).</li> <li>Partner with IT/business teams on validation and upgrades.</li> <li>Develop and implement SOPs and standardized processes, drive process optimization.</li> </ul> <p><strong>Compliance, Inspection Readiness &amp; Governance</strong></p> <ul> <li>Ensure operational compliance with global regulations and internal policies.</li> <li>Lead inspection readiness, training, and documentation oversight.</li> <li>Monitor regulatory changes and assess their impact.</li> </ul> <p><strong>&nbsp;</strong><strong>Qualifications and Preferred Skills</strong></p> <ul> <li>Bachelor’s degree in a scientific, life sciences, or related field required. Advanced degree (MS, PhD, PharmD) preferred.</li> <li>10+ years of relevant industry experience, with majority of experience in Regulatory Operations.</li> <li>Demonstrated experience leading global regulatory submissions across multiple regions.</li> <li>Experienced in building and leading teams and managing outsourced partners.</li> <li>Strong experience with eCTD publishing, regulatory systems (e.g., RIM), and regulatory document management.</li> <li>Experience driving regulatory operations transformation or system implementations.</li> <li>Experience supporting late stage development and regulatory inspections preferred.</li> <li>Deep understanding of global regulatory submission requirements and health authority expectations.</li> <li>Strategic thinker with strong execution, problem solving, and change management skills.</li> <li>Excellent communication, collaboration, and stakeholder management abilities.</li> <li>Strong organizational and project management skills with high attention to detail.</li> <li>Ability to operate effectively in fast paced, evolving environments while maintaining quality and compliance.</li> </ul> <p>&nbsp;</p><div class="content-pay-transparency"><div class="pay-input"><div class="description"><p>Exact Compensation may vary based on skills, experience and location.</p></div><div class="title">Pay range</div><div class="pay-range"><span>$248,000</span><span class="divider">&mdash;</span><span>$310,000 USD</span></div></div></div>