New · posted Oct 15
Mirum Pharmaceuticals · Pharmaceuticals
Director, Regulatory Project Management
- Foster City, CA
- Hybrid
- Full-time
- Director
Open until filled
The role
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.
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.
What you need
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.
Pay
$230,000 – $250,000 a year
Employer providedThe 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.
Where you'll work
Foster City, CAHybridOpen in Maps (opens in a new tab)
More jobs in Foster City, CAWorking conditions
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.
Equal opportunity, accessibility and legal noticesMirum Pharmaceuticals's statements, word for word
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.
Job intelligence
The context around this role
Live data · October 15, 2026
Salary intelligence
How the pay compares
This role's midpoint is 2% above the US median for Regulatory Affairs roles at this level.
This roleEmployer provided
Director roles in California21 roles publishing pay
Director roles in the US101 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $230,000 | — | $250,000 |
| California (middle half) | $223,000 | $244,000 | $282,500 |
| All US (middle half) | $209,500 | $235,000 | $264,000 |
This role: Mirum Pharmaceuticals's own published range. Comparisons: the base pay employers published on open Regulatory Affairs roles at the same level on Regulatory Jobs, October 15, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Regulatory Affairs
The general path across 290 open Regulatory Affairs roles on Regulatory Jobs, with the titles they carry most. Not Mirum Pharmaceuticals's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 12 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership8
- Regulatory submissions2
- Documentation and SOPs1
- Quality systems and risk1
- Data and digital systems1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
- FDAFDA IND(official source, opens in a new tab)Investigational New Drug applications
- FDAFDA NDA(official source, opens in a new tab)New Drug Applications
From Regulatory News
Manufacturing and quality coverage for this professionCompany hiring pulse
Mirum Pharmaceuticals on Regulatory Jobs
- 7
- Open roles
- 7
- Distinct roles
- 1
- Locations
By discipline
- Regulatory5 71%
- Quality2 29%
By level
- Director5 71%
- VP & Executive1 14%
- Manager1 14%
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Director, Regulatory Project Management at Mirum Pharmaceuticals
Open until filled. $230K–$250K a year, employer provided.