Associate Director, Regulatory Affairs - San Diego, CA

<div class="content-intro"><p style="text-align: left; line-height: 1.5;">Mirador is a next-generation precision medicine company focused on immunology and inflammation. The company’s Mirador360^&nbsp;_TM&nbsp;precision development engine leverages the latest advances in human genetics and cutting-edge data science to rapidly advance new precision medicines for patients living with chronic immune-mediated inflammatory and fibrotic diseases. Launched in 2024, Mirador has raised over $400 million from leading life sciences investors and is based in&nbsp;San Diego, CA.</p></div><p><strong>Summary</strong></p> <p>The Associate Director of Regulatory Affairs, within the Regulatory Affairs and Quality organization, is responsible for development and implementation of regulatory affairs strategy as a member of multi-disciplinary pharmaceutical product development teams.&nbsp;</p> <p><strong>Responsibilities</strong></p> <ul> <li>Represent Regulatory Affairs in assigned project meetings and provide regulatory guidance to cross-functional project teams as appropriate; leverage experience in drug and device regulatory affairs to provide guidance to colleagues for preparation of regulatory documents.</li> <li>Serve as Regulatory Affairs contact for external parties (for example, CROs) involved in the conduct of global clinical trials.&nbsp;</li> <li>Develop and implement global regulatory strategy for drug and device submissions to support clinical trials and registration in accordance with applicable regulations/guidelines (for example, U.S. FDA, EMA, ICH, ISO, etc.).</li> <li>Plan, prepare, author, and/or review submissions (for example, IND, CTA, BLA, NDA, MAA, IDE, PMA) to health authorities to support clinical trials, registration, maintenance of registration, and labeling of pharmaceutical products.</li> <li>Oversee interactions with vendor for electronic submissions.</li> <li>May serve as primary liaison with FDA (and other health authorities, as appropriate) for day-to-day interactions.</li> <li>Contribute to the development of competitive regulatory strategies that expedite development, maximize the probability of success, and mitigate risks.</li> <li>Communicate project updates and risks to senior Regulatory management and stakeholders across the organization.</li> <li>Tracking regulatory commitments and deliverables while coordinating with internal and external staff to ensure timely submissions.</li> <li>Coordinate and prepare responses to requests for information from health authorities.</li> <li>Prepare meeting requests, briefing documents, coordinate and prepare teams for meetings with health authorities.</li> <li>Provide input into development of internal documentation practices and systems.</li> <li>Monitor, analyze, and disseminate intelligence on regulatory matters that may affect ongoing development programs.</li> <li>Participate in due diligence evaluations of potential in-license/partnering opportunities.</li> <li>Initiate and contribute to the development of policies and procedures in alignment with GxPs, Guidance, and corporate objectives.</li> </ul> <p><strong>Experience and Qualifications</strong></p> <ul> <li>Bachelor's degree required, with an advanced scientific degree (PhD, PharmD) strongly preferred.</li> <li>8 or more years of experience in Regulatory Affairs; experience in therapeutic areas of company focus is a plus.</li> <li>Regulatory Affairs experience with multiple therapeutic modalities; e.g., biologics, drug/device combination products.</li> <li>Experience with complex clinical trial designs.</li> </ul> <p><strong>Skills and Abilities</strong></p> <ul> <li>Unquestionable integrity, be able to inspire trust and exhibit the highest ethical standards.</li> <li>Excellent communication, verbal and written, and interpersonal skills with strong ability to interact with internal teams and partners across all levels of the organization.</li> <li>Ability to effectively present information and respond to questions from all levels of the organization.</li> <li>Sense of urgency, flawless execution with intense focus on accuracy and accountability.</li> <li>Self-starter, highly motivated, assertive, driven, and hands-on leader.</li> <li>Ability to multi-task in a fast-paced, entrepreneurial, smaller company environment.</li> <li>Operate collaboratively with colleagues across functional areas in a science-driven environment.</li> <li>Ability to work well under pressure and meet time sensitive deadlines.</li> <li>Ability to work across locations and time zones.</li> <li>Highly proficient using Veeva, Microsoft Word, Excel, PowerPoint, Project, and SharePoint; or similar applications and systems.&nbsp;</li> <li>Strong financial business acumen and analytical skills; ability to develop and manage expenditures in accordance with budget.&nbsp;</li> <li>Travel up to 5-10% may be required to meet with vendors and regulators.</li> </ul> <p>The expected base pay range for this position is $170,000 – $200,000 plus bonus, equity, and comprehensive benefits. The base pay range reflects the target range for this position, but individual pay will be determined by additional factors such as job-related skills, experience and relevant education or training. This range may be modified in the future.</p> <p>#LI-onsite</p><div class="content-conclusion"><p><a href="https://www.greatplacetowork.com/certified-company/7085057" target="_blank">Working at Mirador Therapeutics | Great Place To Work®</a></p> <p>All qualified applicants are considered for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability, veteran status or other protected class.</p> <p>Read our <a href="https://miradortx.com/careers-privacy/" target="_blank">Job Applicant Privacy Policy</a></p></div>