Director, Promotional Regulatory Affairs
Core
Strategic leadership in FDA promotional regulations, providing expert guidance and risk assessments for promotional materials across assigned brands.
Role type
Director, Promotional Regulatory Affairs
Builds
Promotional materials and brand strategies compliant with FDA regulations
Domain
Pharmaceutical/Biotech, Regulatory Affairs
Required skills
FDA promotional regulations expertise, risk assessment, strategic planning, regulatory strategy development, liaison with FDA (OPDP/APLB), regulatory training, mentoring
Preferred skills
Advanced degree (PharmD, MS, PhD, JD), strategic decision influencing, experience with Oncology/Respiratory/Cardiovascular therapeutic areas, familiarity with VEEVA PromoMats
Technologies
VEEVA PromoMats
Responsibilities
Review and risk assess promotional materials, develop regulatory strategies, advise business leaders on brand strategy, serve as liaison with FDA, deliver regulatory training, mentor staff
Seniority
Director, strategic leadership