Director, Global Regulatory Affairs Advertising & Promotion
Mirum Pharmaceuticals, Inc.
August 25, 2026
Remote friendly (Foster City, CA)
United States
Corporate Functions
Position Summary
The Director, Global Regulatory Affairs Advertising and Promotion provides strategic and operational regulatory leadership for commercial regulatory activities to ensure compliant, timely achievement of business objectives. Provides regulatory guidance for preparation, review, approval, and submission of advertising and promotional materials.
Responsibilities
- Provide commercial regulatory leadership for assigned programs.
- Serve as subject-matter expert for advertising/promotional materials.
- Liaise with FDA/CDER/OPDP and other health agencies as appropriate.
- Oversee/author commercial regulatory submissions; partner with the Publishing vendor to ensure timely OPDP submissions.
- Represent Advertising & Promotion at labeling meetings and provide strategic guidance.
- Provide regulatory guidance on new concepts and campaigns.
- Maintain current knowledge of FDA regulations/guidance/enforcement precedents and translate into practical recommendations.
- Act as an expert resource for regulatory advice across departments.
- Contribute to process improvements (including MLR Committee).
- Develop and implement regulatory advertising and promotional processes.
- Establish and maintain tracking/planning for materials under review, deliverables, submissions, milestones, deadlines, dependencies, and actions.
Qualifications
- Bachelor’s or advanced degree in a scientific discipline.
- 10–12+ years in Regulatory Affairs, including 10+ years reviewing advertising/promotional materials for prescription drug and/or biologic products.
- Experience reviewing promotional and non-promotional materials in an MLR environment.
- Direct OPDP experience, including promotional material submissions and regulatory strategy.
- Cross-functional team representation experience (desirable).
- Prescription drug labeling experience; familiarity with USPI and/or global labeling documents (preferred).
Required/Preferred Skills
- Strong planning/organizational skills; independently manage multiple projects and priorities.
- Excellent written and verbal communication.
- Deep knowledge of advertising/promotion regulatory requirements.
- OPDP submission/strategy experience.
- ROW marketing regulations knowledge (highly desired).
- Strong negotiation, influence, and interpersonal communication; ability to influence across functions.
Compensation
- Salary range: $240,000–$260,000 USD (base salary only as stated).
Work Environment
- Some travel may be required; may require work outside normal business hours.
The Director, Global Regulatory Affairs Advertising and Promotion provides strategic and operational regulatory leadership for commercial regulatory activities to ensure compliant, timely achievement of business objectives. Provides regulatory guidance for preparation, review, approval, and submission of advertising and promotional materials.
Responsibilities
- Provide commercial regulatory leadership for assigned programs.
- Serve as subject-matter expert for advertising/promotional materials.
- Liaise with FDA/CDER/OPDP and other health agencies as appropriate.
- Oversee/author commercial regulatory submissions; partner with the Publishing vendor to ensure timely OPDP submissions.
- Represent Advertising & Promotion at labeling meetings and provide strategic guidance.
- Provide regulatory guidance on new concepts and campaigns.
- Maintain current knowledge of FDA regulations/guidance/enforcement precedents and translate into practical recommendations.
- Act as an expert resource for regulatory advice across departments.
- Contribute to process improvements (including MLR Committee).
- Develop and implement regulatory advertising and promotional processes.
- Establish and maintain tracking/planning for materials under review, deliverables, submissions, milestones, deadlines, dependencies, and actions.
Qualifications
- Bachelor’s or advanced degree in a scientific discipline.
- 10–12+ years in Regulatory Affairs, including 10+ years reviewing advertising/promotional materials for prescription drug and/or biologic products.
- Experience reviewing promotional and non-promotional materials in an MLR environment.
- Direct OPDP experience, including promotional material submissions and regulatory strategy.
- Cross-functional team representation experience (desirable).
- Prescription drug labeling experience; familiarity with USPI and/or global labeling documents (preferred).
Required/Preferred Skills
- Strong planning/organizational skills; independently manage multiple projects and priorities.
- Excellent written and verbal communication.
- Deep knowledge of advertising/promotion regulatory requirements.
- OPDP submission/strategy experience.
- ROW marketing regulations knowledge (highly desired).
- Strong negotiation, influence, and interpersonal communication; ability to influence across functions.
Compensation
- Salary range: $240,000–$260,000 USD (base salary only as stated).
Work Environment
- Some travel may be required; may require work outside normal business hours.