New · posted Oct 15
Mirum Pharmaceuticals · Pharmaceuticals
Director, Global Regulatory Affairs Advertising & Promotion
- Foster City, CA
- Hybrid
- Full-time
- Director
Open until filled
The role
The Director, Global Regulatory Affairs Advertising and Promotion provides strategic and operational regulatory leadership for all commercial regulatory activities, enabling the business to meet its commercial objectives in a compliant and timely manner. This position will provide leadership as a key member of the Medical, Legal and Regulatory (MLR) and provides experienced regulatory guidance for the preparation, review, approval, and submission of advertising and promotional materials..
The individual is expected to work with a high degree of independence, accountability, reliability, and follow-through; proactively identify and resolve issues; anticipate risks to timelines or execution; and drive assigned activities to completion with limited day-to-day supervision. Significant, novel, or precedent-setting matters should be escalated to senior Regulatory leadership, including a clear assessment of the issue, regulatory implications and risk, available options, and a recommended approach.
This role will report to the Senior Director, Global 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
- Bachelor’s or advanced degree in a scientific discipline, with a minimum of 10-12 years in Regulatory Affairs with a minimum of 10 years of experience in the regulatory review of advertising and promotional materials for prescription drug and/or biologic products
- Demonstrated experience reviewing promotional and non-promotional materials in an MLR environment.
- Direct experience with the FDA’s Office of Prescription Drug Promotion (OPDP), including promotional material submissions and regulatory strategy.
- Experience representing Commercial Regulatory Affairs on cross functional teams is desirable.
- Experience with prescription drug labeling, including familiarity with USPI and/or global labeling documents, is preferred.
- Excellent planning and organizational skills, with a demonstrated ability to independently manage multiple projects and competing priorities..
- Excellent communication skills both in writing and verbally.
Knowledge, Skills and Abilities
- Direct experience with FDA’s Office of Prescription Drug Promotion (OPDP) submissions and strategies.
- Extensive in-depth knowledge of regulatory requirements associated with advertising and promotion of prescription drug products is required.
- Knowledge of and experience with laws and regulations regarding marketing pharmaceuticals in rest of world (ROW) is highly desired.
- Excellent verbal, written, negotiation, influence and interpersonal communication skills are required.
- Capable of critically reviewing complex technical/scientific documents and influencing colleagues across functions.
- Requires ability to work both independently and in a team environment, to set priorities to meet timelines, to motivate and influence others.
- Ability to engage and manage multiple stakeholders to achieve the business objective.
- Operationally excellent.
- Organized with systematic approach to prioritization.
- Process oriented to achieve the business objective.
Skills named in this posting
Pay
$240,000 – $260,000 a year
Employer providedThe salary range for this position is $240,000 to $260,000USD. 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
- This is a high growth, fast paced organization. The ability to be productive and successful in a dynamic work environment is critical.
- Some travel may be required. Responsibilities may require a work schedule that includes working outside of “normal” business hours, to meet business demands of a global company.
JOB FUNCTIONS/RESPONSIBILITIES
- Responsible for providing commercial regulatory leadership for assigned programs.
- Serve as a key Regulatory Advertising & Promotion subject-matter expert for advertising/promotional materials.
- Serve as regulatory liaison to the FDA/CDER/Office of Prescription Drug Promotion (OPDP) and other health agencies, as appropriate.
- Oversee or author commercial regulatory submissions and work closely with the Publishing vendor to ensure the timely submission of promotional materials to the Office of Prescription Drug Promotion (OPDP).
- Represent Commercial Regulatory Advertising and Promotion at labeling meetings and provide strategic regulatory guidance, as appropriate.
- Provide regulatory guidance on new concepts and new campaigns.
- Maintain current knowledge of applicable of FDA regulations, guidance documents, enforcement actions, and relevant regulatory precedents, and translate that knowledge into practical recommendations for the organization.
- Recognized as an expert resource for regulatory advice across departments.
- May contribute to process improvements relevant to commercial regulatory activities, including the MLR Committee.
- Responsible for the development and implementation of regulatory advertising and promotional processes, as necessary.
- Establish and maintain an effective tracking and planning system, including materials under review, upcoming deliverables, regulatory submissions, key milestones, deadlines, dependencies, and outstanding actions, to support visibility, prioritization, and timely execution.
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 22% above the US median for Labeling & Promotion roles at this level.
This roleEmployer provided
Director roles in California11 roles publishing pay
Director roles in the US35 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $240,000 | — | $260,000 |
| California (middle half) | $205,500 | $210,000 | $237,000 |
| All US (middle half) | $197,500 | $205,500 | $216,750 |
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 21 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership8
- Regulatory submissions5
- Documentation and SOPs4
- GMP and compliance1
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.
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, Global Regulatory Affairs Advertising & Promotion at Mirum Pharmaceuticals
Open until filled. $240K–$260K a year, employer provided.