Regulatory Affairs

Location:  This position may be performed remotely, but requires the flexibility and willingness to travel as needed.

The Opportunity

The Assistant Director, Regulatory Affairs, Advertising & Promotion will be the regulatory lead for advertising and promotional activities at Praxis, helping us communicate about our medicines with accuracy, integrity, and urgency as we work to bring high-impact treatments to patients with CNS disorders. 

You will own the regulatory review and approval of promotional materials and partner closely with Commercial, Medical Affairs, Legal, Regulatory Strategy, and Regulatory Operations to build an efficient, rigorous, and scalable promotional review capability. This is a highly visible role for someone who brings strong regulatory judgment, communicates directly, and is comfortable making thoughtful decisions in a fast-moving environment. 

Success in this role requires more than knowing the regulations. You will anticipate issues, challenge assumptions, find compliant paths forward, and help teams solve problems early rather than simply identifying risk at the end of the process. You will operate with significant autonomy and accountability while building trusted partnerships across Praxis. 

Primary Responsibilities

• Own Regulatory Affairs review and approval of advertising and promotional materials across channels, including HCP and DTC materials, digital and social media, sales aids, speaker materials, congress materials, and disease awareness campaigns. 
• Apply strong regulatory judgment to ensure promotional communications are accurate, appropriately balanced, consistent with approved labeling, and compliant with applicable FDA regulations and guidance while helping teams identify practical paths forward. 
• Partner early with Commercial, Medical Affairs, and Legal to shape campaigns and claims, provide clear and actionable guidance, and reduce unnecessary late-stage revisions or approval delays. 
• Own required FDA promotional submissions, including Form FDA 2253 filings, and lead Regulatory Affairs interactions with the FDA Office of Prescription Drug Promotion (OPDP), including responses to inquiries or enforcement communications. 
• Monitor OPDP enforcement activity, evolving FDA guidance, and regulatory trends; translate what matters into clear implications and recommendations for Praxis teams. 
• Build and continuously improve scalable advertising and promotion processes, including effective review practices, compliant records and archiving, coordination with Regulatory Operations, and use of systems such as Veeva PromoMats and RIM. 
• Serve as a trusted regulatory partner across Praxis, including partnering with Regulatory Strategy on product labeling, Medical Affairs on scientific exchange and medical education, and cross-functional teams on market access, pre-approval information exchange (PAIE), launch readiness, and other complex communications.