Associate Director, Regulatory Affairs — Promo (Remote)

Praxis Precision Medicines, Inc.; Northern (KY); Hybrid; USD 200,000 - 221,000; Full time

Job summary

Praxis Precision Medicines, Inc. seeks an Associate Director of Regulatory Affairs (Advertising & Promotion) to lead the regulatory review of promotional materials across channels.

This role will partner with Commercial, Medical Affairs, Legal, and Regulatory Strategy to build a rigorous promotional review process and ensure timely, compliant campaigns for CNS-focused therapies. Ideal candidates bring deep FDA knowledge, strong judgment, and the ability to operate with autonomy in a fast-moving

Qualifications

• Bachelor's degree in a scientific, pharmacy, health-related, or relevant discipline; advanced degree preferred.

Responsibilities

• Own regulatory review and approval of advertising and promotional materials across channels.
• Apply regulatory judgment to ensure communications are accurate, balanced, and compliant with FDA guidance.
• Partner with Commercial, Medical Affairs, and Legal to shape campaigns and reduce revision delays.
• Lead FDA promotional submissions (Form FDA 2253) and OPDP interactions.
• Monitor FDA guidance and translate regulatory trends into actionable recommendations.

Skills

Regulatory judgment

Direct communication

Cross-functional partnership

Autonomy

Decision making

Education

Bachelor's degree in a scientific discipline

Advanced degree (PharmD/MS/PhD/MD/JD) preferred

Tools

Veeva PromoMats

RIM

Job description

Praxis Precision Medicines, Inc. seeks an Associate Director of Regulatory Affairs (Advertising & Promotion) to lead the regulatory review of promotional materials across channels.

This role will partner with Commercial, Medical Affairs, Legal, and Regulatory Strategy to build a rigorous promotional review process and ensure timely, compliant campaigns for CNS-focused therapies. Ideal candidates bring deep FDA knowledge, strong judgment, and the ability to operate with autonomy in a fast-moving