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