Associate Director, Regulatory Affairs, AD Promo

The role

The Assistant Director, Regulatory Affairs, Advertising & Promotion will be the regulatory lead for advertising and promotional activities. You will own the regulatory review and approval of promotional materials and partner with cross-functional teams to build promotional review capabilities.

What you will do

• Own Regulatory Affairs review and approval of advertising and promotional materials across channels
• Apply regulatory judgment to ensure communications are accurate and compliant with FDA regulations
• Partner with Commercial, Medical Affairs, and Legal to shape campaigns and claims
• Own required FDA promotional submissions including Form FDA 2253 filings
• Lead Regulatory Affairs interactions with the FDA Office of Prescription Drug Promotion
• Monitor OPDP enforcement activity, evolving FDA guidance, and regulatory trends
• Build and improve scalable advertising and promotion processes
• Partner with Regulatory Strategy on product labeling and Medical Affairs on scientific exchange

Required qualifications

• Bachelor's degree in a scientific, pharmacy, health-related, or relevant discipline
• 8+ years of pharmaceutical or biopharmaceutical industry experience
• At least 5 years focused on regulatory advertising and promotion
• Deep, current knowledge of FDA requirements and guidance governing prescription drug advertising and promotion
• Demonstrated experience with Form FDA 2253 submissions, OPDP interactions, and review of promotional materials
• Regular use of a computer, devices or other office equipment
• Clear communication
• Occasional movement

Nice to have

• Advanced degree such as a PharmD, MS, PhD, MD, or JD
• Experience supporting product launches, including pre-approval promotional planning and PAIE activities
• Experience in CNS, neurology, or rare disease
• Familiarity with Veeva PromoMats, RIM, or comparable systems

Benefits

• 99% of the premium paid for medical, dental and vision plans
• Company-paid life insurance, AD&D, disability benefits
• Voluntary plans to personalize coverage
• Dollar-for-dollar 401(k) match up to 6%
• Long-term stock incentives
• ESPP
• Discretionary quarterly bonus
• Extremely flexible wellness benefit
• Generous PTO
• Paid holidays
• Company-wide shutdowns

About the company

Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders. The company focuses on developing high impact medicines for patients and families affected by complex brain disorders.