--- title: 'Director, Global Regulatory Affairs Advertising & Promotion at Mirum Pharmaceuticals' canonical: 'https://feeny.ai/job/director-global-regulatory-affairs-advertising-promotion-mirum-pharmaceuticals-aqrxctzd182s' type: 'job' last_seen: '2026-09-09' --- # Director, Global Regulatory Affairs Advertising & Promotion at Mirum Pharmaceuticals - **Company:** Mirum Pharmaceuticals - **Location:** Foster City, CA - **Posted:** 2026-08-24 - **Last confirmed live:** 2026-09-09 - **Apply:** https://job-boards.greenhouse.io/mirumpharmaceuticals/jobs/5219151007 ## Job description ## MISSION Mirum Pharmaceuticals is a biopharmaceutical company dedicated to transforming the treatment of rare diseases. We are passionate about advancing scientific discoveries to become important medicines for rare disease patients. We are collaborative, creative, and experienced professionals and we’re looking to augment our team with other individuals who embody our values: care, be real, get it done, and have fun, seriously. ## POSITION SUMMARY The Director, Global Regulatory Affairs Advertising and Promotion provides strategic and operational regulatory leadership for all commercial regulatory activities, enabling the business to meet its commercial objectives  in a compliant and timely manner. This position will provide leadership as a key member of the Medical, Legal and Regulatory (MLR) and provides experienced regulatory guidance for the preparation, review, approval, and submission  of advertising and promotional materials.. The individual is expected to work with a high degree of independence, accountability, reliability, and follow-through; proactively identify and resolve issues; anticipate risks to timelines or execution; and drive assigned activities to completion with limited day-to-day supervision. Significant, novel, or precedent-setting matters should be escalated to senior Regulatory leadership, including a clear assessment of the issue, regulatory implications and risk, available options, and a recommended approach. This role will report to the Senior Director, Global Regulatory Affairs Labeling. ## JOB FUNCTIONS/RESPONSIBILITIES - Responsible for providing commercial regulatory leadership for assigned programs. - Serve as a key Regulatory Advertising & Promotion subject-matter expert for advertising/promotional materials. - Serve as regulatory liaison to the FDA/CDER/Office of Prescription Drug Promotion (OPDP) and other health agencies, as appropriate. - Oversee or author commercial regulatory submissions and work closely with the Publishing vendor to ensure the timely submission of promotional materials to the Office of Prescription Drug Promotion (OPDP). - Represent Commercial Regulatory Advertising and Promotion at labeling meetings and provide strategic regulatory guidance, as appropriate. - Provide regulatory guidance on new concepts and new campaigns. - Maintain current knowledge of applicable of FDA regulations, guidance documents, enforcement actions, and relevant regulatory precedents, and translate that knowledge into practical recommendations for the organization. - Recognized as an expert resource for regulatory advice across departments. - May contribute to process improvements relevant to commercial regulatory activities, including the MLR Committee. - Responsible for the development and implementation of regulatory advertising and promotional processes, as necessary. - Establish and maintain an effective tracking and planning system, including materials under review, upcoming deliverables, regulatory submissions, key milestones, deadlines, dependencies, and outstanding actions, to support visibility, prioritization, and timely execution. ## QUALIFICATIONS Education /Experience: - Bachelor’s or advanced degree in a scientific discipline, with a minimum of 10-12 years in Regulatory Affairs with a minimum of 10 years of experience in the regulatory review of advertising and promotional materials for prescription drug and/or biologic products - Demonstrated experience reviewing promotional and non-promotional materials in an MLR environment. - Direct experience with the FDA’s Office of Prescription Drug Promotion (OPDP), including promotional material submissions and regulatory strategy. - Experience representing Commercial Regulatory Affairs on cross functional teams is desirable. - Experience with prescription drug labeling, including familiarity with USPI and/or global labeling documents, is preferred. - Excellent planning and organizational skills, with a demonstrated ability to independently manage multiple projects and competing priorities.. - Excellent communication skills both in writing and verbally. Knowledge, Skills and Abilities: - Direct experience with FDA’s Office of Prescription Drug Promotion (OPDP) submissions and strategies. - Extensive in-depth knowledge of regulatory requirements associated with advertising and promotion of prescription drug products is required. - Knowledge of and experience with laws and regulations regarding marketing pharmaceuticals in rest of world (ROW) is highly desired. - Excellent verbal, written, negotiation, influence and interpersonal communication skills are required. - Capable of critically reviewing complex technical/scientific documents and influencing colleagues across functions. - Requires ability to work both independently and in a team environment, to set priorities to meet timelines, to motivate and influence others. - Ability to engage and manage multiple stakeholders to achieve the business objective. - Operationally excellent. - Organized with systematic approach to prioritization. - Process oriented to achieve the business objective. Work Environment: - This is a high growth, fast paced organization. The ability to be productive and successful in a dynamic work environment is critical. - Some travel may be required. Responsibilities may require a work schedule that includes working outside of “normal” business hours, to meet business demands of a global company. The salary range for this position is $240,000 to $260,000USD. Compensation will be determined based on several factors including, but not limited to; skill set, years of experience, and the employee’s geographic location. Please note that the required compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits unless otherwise provided. ## #LI-HYBRID Mirum Pharmaceuticals is committed to Equal Employment Opportunity (EEO) and to compliance with all Federal, State and Local laws that prohibit employment discrimination on the basis of race, age, national origin, ethnicity, religion, gender, gender identity, pregnancy, marital status, sexual orientation, citizenship, genetic disposition or characteristics, disability, veteran’s status or any other classification protected by applicable State/Federal/Local laws. Mirum Pharmaceuticals provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in job application procedures. ## About Mirum Pharmaceuticals ## Company Overview - **One-liner**: Mirum Pharmaceuticals is a global biopharmaceutical company focused on developing and delivering treatments for rare liver diseases affecting children and adults with significant unmet medical needs. - **Entity Type**: Public (NASDAQ: MIRM) - **Headquarters**: Foster City, California, USA - **Founded**: 2018 - **Founders**: Not publicly listed as individual founders; the company was established by a leadership team with deep rare disease and biotech experience who identified a deprioritized therapy for Alagille syndrome and moved decisively to advance it. ## Core Business - **Primary industry/industries**: Biotechnology / Rare Disease Pharmaceuticals - **Target customers**: Healthcare providers, patients, and families affected by rare liver diseases (Alagille syndrome, Progressive Familial Intrahepatic Cholestasis, and other cholestatic conditions); B2B relationships with payers, distributors, and healthcare systems globally. - **Mission or purpose statement**: "Relentlessly Rare" — focused on conditions where the burden is profound and the need is greatest, combining deep expertise with disciplined execution to advance meaningful medicines for people around the world. ## Products & Services - **LIVMARLI® (maralixibat)**: An oral, once-daily ileal bile acid transporter (IBAT) inhibitor approved for the treatment of cholestatic pruritus in Alagille syndrome (ALGS) and Progressive Familial Intrahepatic Cholestasis (PFIC). Approved in multiple regions including the US and Europe. Additional development programs are underway. - **Pipeline Programs**: A broad pipeline of investigational medicines targeting significant unmet needs in rare liver diseases, including additional indications for LIVMARLI and other early-stage programs. ## Market Standing - **Valuation/Market Cap**: As of mid-2025, Mirum’s market capitalization is approximately $1.5–$2.0 billion (fluctuating with stock price; check current data on [ir.mirumpharma.com](https://ir.mirumpharma.com/overview/default.aspx)). - **Key Metric**: Annual Revenue — Mirum generates revenue from commercial sales of LIVMARLI. In 2024, the company reported total revenue of approximately $290 million (preliminary figure; verify in latest 10-K). The company has transitioned from a development-stage to a commercial-stage biotech. - **Notable Investors/Partners**: Public institutional investors; key partners include clinical sites, patient advocacy groups (e.g., Alagille Syndrome Alliance, PFIC Network), and global distribution partners for international markets. - **Growth Signals**: Three approved medicines in its portfolio; global footprint with offices in North America and Europe; expanding pipeline with additional clinical programs; consistent revenue growth from LIVMARLI; growing commercial presence in Europe and other regions. ## Competitive Advantages - **First-in-class / Best-in-class therapy**: LIVMARLI is the first and only approved treatment for cholestatic pruritus in Alagille syndrome, addressing a critical unmet need with no prior approved therapies. - **Deep rare disease expertise**: The leadership team has extensive experience in rare disease drug development, regulatory strategy, and commercialization, allowing the company to navigate complex pathways efficiently. - **Patient-centric culture**: Mirum embeds patient and family voices directly into development and commercial strategy, ensuring therapies meet real-world needs. - **Disciplined execution**: The company was founded with a single deprioritized asset and rapidly advanced it to approval, demonstrating agility and focus. ## Strategic Focus - **Expand global access**: Continuing to secure regulatory approvals and market access for LIVMARLI and other pipeline assets across North America, Europe, and other regions. - **Advance pipeline**: Pursuing additional indications for LIVMARLI and developing new therapies for other rare liver diseases with high unmet need. - **Deepen patient engagement**: Strengthening relationships with patient communities and advocacy groups to inform research, development, and commercialization. - **Build commercial infrastructure**: Expanding commercial, medical affairs, and patient services teams globally to support growing product portfolio. ## Why Work Here - **Mission-driven culture**: Mirum’s core values — "Care, Be Real, Get It Done, and Have Fun, Seriously" — foster a collaborative, high-performance environment where employees are empowered to bring their authentic selves to work. - **Flexible work environment**: The company supports flexible ways of working, with offices in Foster City (global HQ), Basel (Switzerland), and Zug (Switzerland), plus US Remote roles available for certain positions. Arrangements vary by role. - **Comprehensive benefits**: 100% employee medical premium coverage (with 100% dependent medical contributions), 4% 401(k) match with immediate vesting, 15% Employee Stock Purchase Plan, four weeks of PTO starting day one, company holidays including a winter shutdown, paid parental leave, up to $5,000 annual tuition reimbursement, and an Employee Assistance Program. - **Collaborative community**: Regular "Coffee and Chats" and bi-weekly "Lunch Connections" foster cross-functional dialogue. Office environments are designed for connection with stocked snacks, beverages, and (in some locations) catered lunches and on-site baristas. - **Growth opportunity**: As a high-growth public company with approved products and an expanding pipeline, employees have significant opportunities to contribute to meaningful milestones and career development. ## Sources 1. [mirumpharma.com](https://mirumpharma.com/) 2. [mirumpharma.com/about-us/our-story/](https://mirumpharma.com/about-us/our-story/) 3. [mirumpharma.com/jobs/](https://mirumpharma.com/jobs/) 4. [ir.mirumpharma.com](https://ir.mirumpharma.com/overview/default.aspx) 5. 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