Director, Regulatory Affairs, Advertising & Promotion (Remote)
Director, Regulatory Affairs, Advertising & Promotion (Remote) In this role, you will lead advertising and promotion regulatory strategy, shape product messaging, and support compliant commercialization activities while collaborating with Commercial, Medical Affairs, Legal, and Regulatory stakeholders. When & where:
- Work Location: Remote - United States
- Remote:5 days per week on site
Discover your role:
- Lead US and global regulatory activities supporting advertising, promotion, and commercialization initiatives.
- Advise on product messaging and promotional materials across functional areas.
- Provide regulatory guidance for conference exhibits, disease awareness, and speaker programs.
- Review promotional and disease-state communications for compliance with applicable requirements.
- Partner with Marketing, Medical Affairs, Legal, and Regulatory Therapeutic Area Leads.
- Oversee FDA promotional interactions, advisory submissions, and Form 2253 compliance.
- Drive process improvements and portfolio-wide promotional policy standardization.
- You build trusted relationships that influence decisions across complex stakeholder groups.
This role requires:
- Master's, PharmD, or PhD; or a Bachelor's degree in Life Sciences from an accredited institution.
- Minimum 7 years of biotechnology or pharmaceutical industry experience.
- Deep expertise in advertising and promotion regulations, guidance, and development precedents.
- Experience supporting pharmaceutical products; biologics experience is a plus.
- Experience working directly with FDA Office of Prescription Drug Promotion (OPDP) and Advertising and Promotional Labeling Branch (APLB).
- Experience reviewing promotional materials and supporting product launches or campaigns.
- Knowledge of commercialization strategy, labeling development, and marketing application content.
- Experience with global promotional review, clinical trial recruitment materials, and labeling regulations preferred.
- Experience leading teams, influencing cross-functional stakeholders, and working with senior management.
- Strong written and verbal communication skills for strategic regulatory guidance.
Salary Range (annually) $205,000.00 - $341,600.00 Apply To This Job