Associate Director, Promotional Regulatory Affairs
Core
Lead review and adjudication of promotional materials for pharmaceutical products in the US, providing regulatory guidance and risk assessment to ensure compliance with FDA regulations.
Role type
Senior individual contributor regulatory affairs lead
Builds
Compliant promotional assets and training programs for HCP, Consumer, and Managed Markets
Domain
Pharmaceutical regulatory affairs (US FDA)
Required skills
FDA promotional regulations knowledge, drug development process understanding, electronic review program proficiency, risk assessment, strategic planning, project management
Preferred skills
Therapeutic area expertise, influencing decision-making, cross-functional collaboration, training development
Technologies
VEEVA PromoMats
Responsibilities
Lead review and adjudication of promotional materials; Provide regulatory advice and support to cross-functional partners; Manage FDA advisory review requests; Develop and deliver regulatory training; Monitor regulatory agency activities and emerging trends
Seniority
Senior, hands-on IC with leadership responsibilities