---
title: 'Director, Regulatory Project Management at Mirum Pharmaceuticals'
canonical: 'https://feeny.ai/job/director-regulatory-project-management-mirum-pharmaceuticals-foster-city-4jg70n1k4q9c'
type: 'job'
last_seen: '2026-10-14'
---

# Director, Regulatory Project Management at Mirum Pharmaceuticals

- **Company:** Mirum Pharmaceuticals
- **Location:** Foster City, CA
- **Posted:** 2026-10-12
- **Last confirmed live:** 2026-10-14
- **Apply:** https://job-boards.greenhouse.io/mirumpharmaceuticals/jobs/5263663007

## 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, Regulatory Project Management provides strategic leadership and oversight for the planning and execution for Regulatory Medical Writing (RMW) Department deliverables, including, high-quality regulatory submissions of original applications (i.e., NDAs, MAAs, INDs, etc.), rare disease designations, major supplements/variations, and lifecycle submissions for assigned programs. This position will contribute to regulatory submission strategy, working in close collaboration with the RMW team, Global Regulatory Lead (GRL), as well as cross-functional teams to identify submission risks and opportunities, define regulatory deliverables, and build timelines/dashboards to support regulatory filings through licensure and beyond.

The Director also serves as a senior advisor to leadership, guiding decision-making, resource planning, and continuous improvement of RMW processes.

## JOB FUNCTIONS/RESPONSIBILITIES

- Responsible for partnering across the RMW Department (Strategic Regulatory, CMC Regulatory, Labeling, Ad-Promo, Regulatory Information Management, and Medical Writing) and with cross-functional project teams to ensure regulatory timelines/strategies are developed and seamlessly executed upon, enabling successful filings with Global Health Authorities.
- Co-lead Global Regulatory Project Team (GRPT) meetings in partnership with GRL.
- Co-lead product/submission-specific multi-disciplinary Filing Teams – working with all major contributors to set expectations and ensure timelines are met.
- Develop/actively manage project timelines and integrated submission project plans to ensure timelines remain on schedule.
- Work with each function to understand individual deliverables and interdependencies between deliverables to create and maintain an overall project plan timeline across all Modules (Modules 1-5).
- Identify and communicate both regulatory and project risks – providing potential solutions to the cross-functional project team and leadership as needed.
- Prepare meeting agendas, meeting minutes and document decisions/action items/risk mitigation plans. Organize and maintain this team information in a central location.
- Prepare and distribute reports/trackers to communicate updates and project status.
- Proactively drive project/submission teams and establish an appropriate level of urgency with a keen focus on deliverables.
- Conduct lessons learned sessions to identify areas for improvement.
- Standardize processes/dashboards to manage overall, cross-portfolio RMW submission workload.
- Track overview of major submission and health authority activity to aid in Regulatory resource planning.
- Organize key aspects of the regular RMW Department on site activities as needed.
- Support the Head of Regulatory Project Management & Information Systems as required.

## QUALIFICATIONS

Education /Experience:

- Bachelor’s degree in biological or life sciences or related scientific discipline, pharmacy or medicine (or international equivalent). An advanced degree is desirable.
- 10+ years in the pharmaceutical industry with a deep understanding of drug development.
- Prior project management experience with NDA/MAA/Lifecycle submissions and review is required.

Knowledge, Skills and Abilities:

- Expert in project management with advanced expertise using related software and tools (e.g. MS Project, Sharepoint, Veeva, etc).
- Demonstrated experience in leading decision-making within cross-functional teams.
- Excellent organizational and communication skills, both written and verbal.
- Ability to work independently, influence senior stakeholders, set strategic project direction, and manage ambiguity.
- Proactive, collaborative, and solution-oriented with strong organizational discipline.
- Strong interpersonal skills and the ability to lead, mentor, and develop regulatory project managers/other junior staff as needed.

The salary range for this position is $230,000 to $250,000USD. 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. [job-boards.greenhouse.io/mirumpharmaceuticals](https://job-boards.greenhouse.io/mirumpharmaceuticals)

## Other roles at Mirum Pharmaceuticals

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- [Associate Director, Commercial Operations](https://feeny.ai/job/associate-director-commercial-operations-mirum-pharmaceuticals-zug-8badj97bpf21) — Zug, Switzerland
- [Therapeutic Account Manager, Liver - Baltimore](https://feeny.ai/job/therapeutic-account-manager-liver-baltimore-mirum-pharmaceuticals-baltimore-wsmckesc300t) — Baltimore, MD
- [Senior Director, Regulatory Affairs](https://feeny.ai/job/senior-director-regulatory-affairs-mirum-pharmaceuticals-foster-city-c00xsafh10k8) — Foster City, CA
- [Senior Director, Shared Services](https://feeny.ai/job/senior-director-shared-services-mirum-pharmaceuticals-foster-city-aedy0jj99pbz) — Foster City, CA
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- [Therapeutic Account Manager, Liver - Dallas](https://feeny.ai/job/therapeutic-account-manager-liver-dallas-mirum-pharmaceuticals-dallas-ypgscmz65nhr) — Dallas, TX
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