---
title: 'Senior Director, Regulatory Affairs at Mirum Pharmaceuticals'
canonical: 'https://feeny.ai/job/senior-director-regulatory-affairs-mirum-pharmaceuticals-foster-city-c00xsafh10k8'
type: 'job'
last_seen: '2026-10-14'
---

# Senior Director, Regulatory Affairs at Mirum Pharmaceuticals

- **Company:** Mirum Pharmaceuticals
- **Location:** Foster City, CA
- **Posted:** 2026-09-30
- **Last confirmed live:** 2026-10-14
- **Apply:** https://job-boards.greenhouse.io/mirumpharmaceuticals/jobs/5252615007

## 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 Senior Director, Global Regulatory Affairs will play a significant role in providing regulatory strategic leadership on multiple clinical development programs associated with rare diseases in assigned Therapeutic Area (TA). This role will represent the regulatory function and provide guidance to Program Teams across the organization which include Clinical Development, Clinical Operations, Biometrics, Nonclinical Science, Drug Safety and Pharmacovigilance, and Quality Assurance for assigned projects. This role will be the Global Regulatory TA Lead, responsible for ensuring global regulatory compliance and overseeing timely delivery of submissions and approvals of regulatory procedures including but not limited to IND, NDA, MAA, and life cycle management activities for multiple projects.

## JOB FUNCTIONS/RESPONSIBILITIES

- Develops and oversees the global regulatory strategy for projects in assigned TA, in conjunction with and under the leadership of the SVP, Global Regulatory Affairs.
- Leads the Global Regulatory Project Team meetings in collaboration with Regulatory Project Management when being the Global Regulatory Lead on a project.
- Oversees the preparation of regulatory documentation (meeting request/briefing books) in support of interactions with a Health Authority and provide guidance to their team.
- Oversees/leads the preparation and the critical review of submission documents to ensure compliance with regulatory requirements.
- Contributes to and reviews responses to global Health Authority questions to ensure appropriate, consistent, and complete responses, ensuring their alignment with global development strategy.
- Provide global regulatory advice through the product life cycle by representing the regulatory function in the Program Team when being the Global Regulatory Lead on a project.
- In partnership with Regulatory Project Management, Regulatory Labelling and Regulatory CMC, oversees the development of content and format for regulatory submissions and related variations/amendments internationally in assigned TA.
- Actively participates in Health Authority meetings.
- Clearly articulate regulatory challenges/risks, identify potential solutions, and make a recommendation(s) on a path forward to Program Teams and Senior Management.
- Responsible for maintaining a working knowledge of regulatory requirements and guidelines and for communicating regulatory changes to Program Teams.
- Effectively manages direct report(s) and provide mentorship to junior professionals.

## QUALIFICATIONS

Education /Experience:

- Bachelor’s or Master’s degree in biological or life sciences or related scientific discipline, pharmacy or medicine (or international equivalent); an advanced degree is desirable.
- A minimum of 15 years in the pharmaceutical industry with a minimum of 12 years in Global Regulatory Affairs, experience with major Health Authorities (US FDA, Health Canada, and EMA) is mandatory.
- Strong understanding of US FDA, EU and international pharmaceutical guidance, regulations, drug development process, and industry standard practices.
- Experience with major regulatory submissions (e.g. New Drug Applications (NDA/NDS/MAA), Paediatric Investigation Plans (PIP) and Orphan Drug Designation (ODD) activities) is highly preferred.
- Experience in all phases of development and post marketing activities is highly preferred.
- Demonstrated ability to analyze and interpret efficacy and safety data.
- Strong understanding of regulatory operational activities.
- Outstanding people management skills are required.
- Outstanding interpersonal and communication skills.
- Experience in strategic problem-solving and negotiation with Health Authorities and leading internal teams on the regulatory strategy for a given product is required.
- Demonstrated proficiency in organizational awareness, including experience working cross-functionally representing the Regulatory Affairs function and on global teams.
- Excellent planning and organizational skills and ability to work simultaneously on multiple projects with tight timelines.
- Supports the SVP, Global Regulatory Affairs as required.

Work Environment:

- This is a high-growth, fast-paced organization. The ability to be productive and a team player is critical.
- Ability to work under minimal supervision.
- Willingness and ability to travel domestically and internationally is required, it is anticipated that this will be 10-15% of work time.
- On site presence at the headquarters is required (minimum 2 days a week).

The salary range for this position is $280,000 to $310,000 USD. 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)

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