Associate Director, Regulatory Affairs Advertising and Promotion
Mirum Pharmaceuticals, Inc.
11 days ago
Remote friendly (Foster City, CA)
United States
Marketing
Position Summary
The Associate Director, Regulatory Affairs Advertising and Promotion provides regulatory guidance on commercial regulatory activities to enable the business to meet its commercial needs in a compliant manner. This role will provide regulatory guidance as a member of the Medical, Legal and Regulatory (MLR) team.
Responsibilities
- Provide commercial regulatory oversight for assigned programs.
- Manage and author commercial regulatory submissions; partner with a publishing vendor to ensure timely publishing and OPDP submission of promotional materials.
- Provide regulatory guidance on new concepts and new campaigns.
- Maintain awareness of FDA regulations, guidance documents, and enforcement actions related to pharmaceutical advertising and 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; minimum 6 years reviewing advertising and promotional materials for prescription drugs and/or biologics.
- Experience representing Commercial Regulatory Affairs on cross-functional teams (desirable).
- Excellent planning/organizational skills; ability to manage multiple projects with tight timelines.
- Excellent written and verbal communication.
Skills/Knowledge
- Experience with FDA OPDP submissions and strategies.
- In-depth knowledge of regulatory requirements for advertising and promotion of prescription drug products.
- Knowledge of ROW marketing laws/regulations (highly desired).
- Strong verbal/written/negotiation/influence/interpersonal communication.
- Ability to critically review complex technical/scientific documents and influence across functions.
- Ability to work independently and in a team; prioritize and meet timelines.
- Ability to engage multiple stakeholders; organized and process-oriented.
Work Environment
- Some travel required; may require working outside normal hours.
Compensation
- Salary range: $205,000 to $225,000 USD (base salary only).
Application instructions
Not specified.
The Associate Director, Regulatory Affairs Advertising and Promotion provides regulatory guidance on commercial regulatory activities to enable the business to meet its commercial needs in a compliant manner. This role will provide regulatory guidance as a member of the Medical, Legal and Regulatory (MLR) team.
Responsibilities
- Provide commercial regulatory oversight for assigned programs.
- Manage and author commercial regulatory submissions; partner with a publishing vendor to ensure timely publishing and OPDP submission of promotional materials.
- Provide regulatory guidance on new concepts and new campaigns.
- Maintain awareness of FDA regulations, guidance documents, and enforcement actions related to pharmaceutical advertising and 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; minimum 6 years reviewing advertising and promotional materials for prescription drugs and/or biologics.
- Experience representing Commercial Regulatory Affairs on cross-functional teams (desirable).
- Excellent planning/organizational skills; ability to manage multiple projects with tight timelines.
- Excellent written and verbal communication.
Skills/Knowledge
- Experience with FDA OPDP submissions and strategies.
- In-depth knowledge of regulatory requirements for advertising and promotion of prescription drug products.
- Knowledge of ROW marketing laws/regulations (highly desired).
- Strong verbal/written/negotiation/influence/interpersonal communication.
- Ability to critically review complex technical/scientific documents and influence across functions.
- Ability to work independently and in a team; prioritize and meet timelines.
- Ability to engage multiple stakeholders; organized and process-oriented.
Work Environment
- Some travel required; may require working outside normal hours.
Compensation
- Salary range: $205,000 to $225,000 USD (base salary only).
Application instructions
Not specified.