Associate Director, Promotional Regulatory Affairs (BBU)
Core
Lead regulatory review and risk assessment of pharmaceutical promotional materials to ensure compliance with US FDA regulations and support business initiatives.
Role type
Senior individual contributor regulatory affairs manager
Builds
Compliant promotional assets for healthcare professionals, consumers, and managed markets
Domain
Pharmaceutical industry, US regulatory compliance
Required skills
FDA promotional regulations, drug development process, risk assessment, regulatory strategy, training development, competitor complaint adjudication
Preferred skills
Therapeutic area expertise, electronic review systems (VEEVA PromoMats), influencing decision-making, strategic thinking
Technologies
VEEVA PromoMats
Responsibilities
Lead review and adjudication of promotional materials through the AZAP process; Provide regulatory guidance and risk assessment to business teams; Represent the company to regulatory authorities; Develop PRA guidance and job aids; Manage FDA advisory review requests; Monitor regulatory agency activities and emerging trends
Seniority
Senior, hands-on IC