Associate Director, Regulatory Affairs Advertising and Promotion
Mirum Pharmaceuticals, Inc.
August 24, 2026
Remote friendly (Foster City, CA)
United States
Corporate Functions
Position Summary
Associate Director, Regulatory Affairs Advertising and Promotion provides regulatory guidance on commercial regulatory activities to support compliant advertising and promotional submissions.
Responsibilities
- Provide commercial regulatory oversight for assigned programs.
- Manage and author commercial regulatory submissions; work with the Publishing vendor to ensure timely publishing and submission of promotional materials to the Office of Prescription Drug Promotion (OPDP).
- Provide regulatory guidance on new concepts and new campaigns.
- Maintain awareness of FDA regulations, guidance documents, and enforcement actions related to pharmaceutical advertising/promotion; monitor enforcement trends and advise the team.
- Serve as a resource for commercial regulatory advice across departments.
- Contribute to process improvements relevant to commercial regulatory activities (including the MLR Committee).
- Support development and implementation of regulatory advertising and promotional processes.
Qualifications
- Bachelor’s or advanced degree in a scientific discipline.
- Minimum 8 years in Regulatory Affairs, including at least 6 years reviewing advertising and promotional materials for prescription drug and/or biologic products.
- Experience representing Commercial Regulatory Affairs on cross-functional teams (desirable).
Required/Preferred Skills
- FDA OPDP submissions and strategies.
- In-depth knowledge of advertising/promotion regulatory requirements for prescription drugs.
- Laws/regulations for marketing pharmaceuticals in rest of world (ROW) (highly desired).
- Strong written/verbal communication; negotiation, influence, and interpersonal skills.
- Ability to critically review complex technical/scientific documents; influence across functions.
- Independent and team-based prioritization to meet tight timelines; engage multiple stakeholders.
Work Environment
- High-growth, fast-paced; some travel required; may require work outside normal hours.
Compensation
- Salary range: $205,000 to $225,000 USD (base salary only; bonus/equity/benefits not included unless otherwise provided).
Associate Director, Regulatory Affairs Advertising and Promotion provides regulatory guidance on commercial regulatory activities to support compliant advertising and promotional submissions.
Responsibilities
- Provide commercial regulatory oversight for assigned programs.
- Manage and author commercial regulatory submissions; work with the Publishing vendor to ensure timely publishing and submission of promotional materials to the Office of Prescription Drug Promotion (OPDP).
- Provide regulatory guidance on new concepts and new campaigns.
- Maintain awareness of FDA regulations, guidance documents, and enforcement actions related to pharmaceutical advertising/promotion; monitor enforcement trends and advise the team.
- Serve as a resource for commercial regulatory advice across departments.
- Contribute to process improvements relevant to commercial regulatory activities (including the MLR Committee).
- Support development and implementation of regulatory advertising and promotional processes.
Qualifications
- Bachelor’s or advanced degree in a scientific discipline.
- Minimum 8 years in Regulatory Affairs, including at least 6 years reviewing advertising and promotional materials for prescription drug and/or biologic products.
- Experience representing Commercial Regulatory Affairs on cross-functional teams (desirable).
Required/Preferred Skills
- FDA OPDP submissions and strategies.
- In-depth knowledge of advertising/promotion regulatory requirements for prescription drugs.
- Laws/regulations for marketing pharmaceuticals in rest of world (ROW) (highly desired).
- Strong written/verbal communication; negotiation, influence, and interpersonal skills.
- Ability to critically review complex technical/scientific documents; influence across functions.
- Independent and team-based prioritization to meet tight timelines; engage multiple stakeholders.
Work Environment
- High-growth, fast-paced; some travel required; may require work outside normal hours.
Compensation
- Salary range: $205,000 to $225,000 USD (base salary only; bonus/equity/benefits not included unless otherwise provided).