Associate Director, Regulatory Affairs, AD Promo

Role: Assistant Director, Regulatory Affairs, Advertising & Promotion, serving as the regulatory lead for promotional activities at Praxis, focusing on CNS disorders. Responsibilities: review and approve advertising materials across channels (HCP, DTC, digital, social media), ensure compliance with FDA regulations, partner with Commercial, Medical, Legal, and Regulatory teams to shape campaigns, manage FDA submissions (Form FDA 2253), monitor regulatory trends, and improve promotional review processes. Requirements: Bachelor's in a relevant scientific or health discipline; 8+ years in pharma/biopharma, with at least 5 years in regulatory advertising and promotion; deep knowledge of FDA promotional regulations; experience supporting product launches, especially in CNS or rare diseases, with familiarity in FDA submissions and review systems like Veeva PromoMats preferred. HighValue: CNS disorders, prescription drug advertising, FDA promotional compliance, product launch support. WorkSetup: remote with flexibility for travel.