Associate Director, Regulatory Affairs, AD Promo
Core
Lead regulatory review and approval of advertising and promotional materials for CNS disorder medicines, ensuring compliance with FDA regulations while partnering with Commercial, Medical Affairs, and Legal teams. (via careerplan.io/jobs/5407713008-associate-director-regulatory-affairs-ad-promo-at-praxisprecisionmedicines)
Role type
Senior individual contributor regulatory affairs lead (pharmaceuticals)
Builds
Scalable promotional review processes and compliant communication channels for HCP and DTC materials
Domain
Biopharmaceuticals, Central Nervous System (CNS) disorders, FDA regulatory compliance
Required skills
FDA promotional regulations expertise, Form FDA 2253 submissions, OPDP interaction experience, promotional material review across digital/social/HCP/DTC channels, regulatory judgment in gray areas, process improvement, cross-functional partnership
Preferred skills
Product launch support (PAIE), CNS/neurology/rare disease experience, Veeva PromoMats/RIM familiarity, advanced degree (PharmD, MS, PhD, MD, JD)
Technologies
Veeva PromoMats, RIM
Responsibilities
Own regulatory review and approval of advertising and promotional materials across all channels; Apply regulatory judgment to ensure accuracy and compliance with FDA guidance; Partner early with Commercial, Medical Affairs, and Legal to shape campaigns; Own FDA promotional submissions and lead interactions with the FDA OPDP; Monitor OPDP enforcement activity and translate trends into team recommendations; Build and improve scalable advertising and promotion processes; Serve as a trusted regulatory partner across the organization
Seniority
Senior, hands-on IC