New · posted Oct 15
Mirum Pharmaceuticals · Pharmaceuticals
Senior Manager, Regulatory Affairs Labeling
- Foster City, CA
- Hybrid
- Full-time
- Manager
Open until filled
The role
The Senior Manager (SM), Regulatory Affairs Labeling will play a key role in providing regulatory expertise and guidance to internal stakeholders for successful development and implementation of global regulatory labeling strategy and documentation for marketed products. The SM/AD will have the opportunity to partner with all Regulatory Affairs functions, Medical Affairs, Legal, Clinical Development, Commercial and International distributors and will play a lead role on the Label Working Group. This role will report to the Senior Director, Global Commercial Regulatory Affairs & Labeling.
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
- Bachelors or advanced degree in a scientific discipline, with a minimum of 3-6 years of regulatory labeling experience in the biopharmaceutical industry.
- Experience with writing, developing, maintaining product labeling in the US and EU; experience around the globe is desirable including LATAM, Middle East, and Asia-Pacific.
- Experience representing Regulatory Affairs Labeling on cross functional teams.
Knowledge, Skills and Abilities
- Excellent verbal, written, negotiation, influence and interpersonal communication skills are required.
- Requires ability to work both independently and in a team environment, to set priorities to meet timelines, to motivate and influence others. Must be self-directed.
- Experience leading a team to project completion on deadline.
- Capable of critically reviewing complex technical/scientific documents.
- Experience with global rules and regulations regarding labeling of medical products is highly desirable, as is experience with US FDA and international Health Authorities.
- Experience with using Veeva Vault RIM and QualityDocs is desirable.
- Resilient profile with the ability to deliver in an ambiguous environment.
- Ability to engage multiple stakeholders to achieve the business objective, while building excellent working relationships.
- Strong team player that is solution oriented.
- Operationally excellent; ability to work simultaneously on multiple projects with tight timelines.
- Organized with systematic approach to prioritization.
- Process oriented to achieve the business objective.
Pay
$175,000 – $195,000 a year
Employer providedThe salary range for this position is $175,000 to $195,000 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.
Where you'll work
Foster City, CAHybridOpen in Maps (opens in a new tab)
More jobs in Foster City, CAWorking conditions
- This is a high growth, fast paced pharmaceutical company. The ability to be productive and successful in such a work environment is critical.
- Some travel required. Responsibilities will require a flexible work schedule that may include periodically working outside of regular business hours, to meet business demands in a company with activities taking place around the globe.
JOB FUNCTIONS/RESPONSIBILITIES
- Create and update labeling content for assigned programs of marketed product(s) and development products in US and international regions including: CCDS, prescribing information, medication guides, patient information/leaflet/IFU, package label artwork.
- Conduct research on competitors and other relevant labeling precedents to support high quality, commercially valid labels for Mirum products.
- Develop project timelines and manage labeling projects from initiation to completion.
- Represent Regulatory Affairs at labeling meetings and provide strategic regulatory guidance, as appropriate.
- Leadership role in Label Working Group and internal review and approval process of labeling documents.
- Ensure labeling is compliant with local country regulations and guidances. This can be accomplished by managing and utilizing local resources (e.g., in-country or in-region labeling consulting services)
- Author or collaborate with regulatory colleagues on regulatory submissions of labeling documents (package inserts, container labeling artwork).
- Liaise with external partners or distributors in international markets, as applicable.
- Support International Regulatory Affairs colleagues when responding to local health authority queries about product labeling.
- Act as primary contact for translation vendors in development of labeling documents in foreign languages.
- Represent Global Regulatory Affairs on the Global Artwork Team; help develop, review and approve global package artwork in close collaboration with Supply Chain and Quality Assurance and International Regulatory Affairs colleagues.
- Coordinate with multidisciplinary team for implementation of commercial labeling updates.
- Serve as an expert resource for regulatory labeling advice across departments.
- Maintain a continued awareness and understanding of FDA, EU, and international health authority regulations, guidance documents with regards to product labeling for pharmaceutical products; assess impact of new regulations on Mirum products.
- Manage labeling archive and internal trackers.
- Contribute to the optimization and implementation of processes and procedures, including developing and authoring internal work instructions and company SOPs and identifying solutions for process optimization and efficiency.
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 24% above the US median for Labeling & Promotion roles at this level.
This roleEmployer provided
Manager roles in the US19 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $175,000 | — | $195,000 |
| All US (middle half) | $143,000 | $149,500 | $172,250 |
This role: Mirum Pharmaceuticals's own published range. Comparisons: the base pay employers published on open Labeling & Promotion roles at the same level on Regulatory Jobs, October 15, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Labeling & Promotion
The general path across 74 open Labeling & Promotion 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 17 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership8
- Regulatory submissions5
- Documentation and SOPs3
- GMP and compliance1
- Data and digital systems1
Company 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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Senior Manager, Regulatory Affairs Labeling at Mirum Pharmaceuticals
Open until filled. $175K–$195K a year, employer provided.