---
title: 'Senior Director, Regulatory Affairs CMC at Mirum Pharmaceuticals'
canonical: 'https://feeny.ai/job/senior-director-regulatory-affairs-cmc-mirum-pharmaceuticals-foster-city-zr7p94a7x2pz'
type: 'job'
last_seen: '2026-09-16'
---

# Senior Director, Regulatory Affairs CMC at Mirum Pharmaceuticals

- **Company:** Mirum Pharmaceuticals
- **Location:** Foster City, CA
- **Posted:** 2026-02-16
- **Last confirmed live:** 2026-09-16
- **Apply:** https://job-boards.greenhouse.io/mirumpharmaceuticals/jobs/5052439007

## 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.

## POSTION SUMMARY

The Senior Director, Regulatory Affairs CMC is a position requiring a strong leader who will provide strategic and operational leadership, and who will ensure the effectiveness of the Regulatory Affairs CMC team within the Regulatory Affairs department and across the organization. The position will be responsible for all CMC-related submissions: strategic planning, execution, and ensuring quality and accurate supporting documents are submitted within the agreed upon timelines. The ideal candidate will need to be able to accurately interpret and discuss CMC data within cross-functional teams and with Health Authorities.

## JOB FUNCTIONS/RESPONSIBILITIES

- Oversees the development and implementation of all regulatory CMC strategies to support market applications, post-marketing CMC commitments, and global development programs across Mirum portfolio.
- Directly leads the regulatory CMC strategy for assigned projects.
- Responsible for ensuring the appropriate execution of all regulatory CMC strategies.
- Actively seeks out knowledge of overall corporate planning, business objectives, and current regulatory requirements to develop regulatory positions for assets in Mirum portfolio, and incorporates this knowledge into submission planning.
- Ensures the effectiveness of the Regulatory CMC team in developing submissions and in working across functions.
- Clearly articulates regulatory challenges/risks, identify potential solutions, leads the preparation of risk assessments on regulatory CMC topics, and effectively oversees change controls
- Builds and manages relationships through active partnering with key internal and external stakeholders.
- Ensures CMC dossiers meet ICH format and content requirements, as well as specific local requirements of individual countries.
- Analyzes and exercises judgment on complex issues, guided by a thorough understanding of CMC.
- Supports regulatory submissions (NDA, MAA, etc.), Briefing Packages, and response documents for Health Authority interactions and address questions/requests, as well as annual updates (e.g., IB, NDA ARs, IND ARs).
- Previous experience leading CMC discussion during meetings with Health Authorities, and regulatory CMC strategy for small molecule, biologics and orphan/breakthrough programs.
- Effectively manages direct report(s) and provides mentorship to junior professionals.

## QUALIFICATIONS

Education/Experience:

- A minimum of 12 years of relevant experience in Regulatory Affairs CMC.
- Experience in drug development focused on market applications (NDA, sNDA, MAA and variations), investigational applications (INDs, CTAs) and commercial lifecycle.
- Advanced degree in a relevant scientific discipline required, PhD in chemistry or other relevant scientific field is a plus.
- Must have experience with small molecules and biologics regulatory CMC activities, late-stage development through commercialization.
- Combination product experience/knowledge preferred.
- Demonstrated track record of successful submissions to FDA and/or other Health Authorities, including EMA. Regulatory experience/exposure to Japan and China is a plus, and other regions/countries (e.g., Canada, LATAM, MENA, Australia/NZ) is a plus.
- Ability to apply scientific principles to assess regulatory issues, request and collect relevant information, analyze data, establish facts and draw valid conclusions.
- Excellent interpersonal, verbal and written communication skills as well as the ability to effectively partner with and influence others are essential in this collaborative work environment.
- Outstanding people management and mentorship skills are required.
- Excellent planning and organizational skills and ability to work simultaneously on multiple projects with tight timelines.
- Comfortable in a fast-paced, small company environment with minimal direction and able to adjust workload based upon changing priorities.

Work Environment:

- This is a high-growth, fast-paced organization. The ability to be productive and a team player s critical.
- Ability to work under minimal supervision.
- Willingness and ability to travel domestically and internationally is required. It is anticipated that this will be 5-10% of work time.

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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