Remote Director, Regulatory Affairs – Advertising

Praxis Precision Medicines, Inc.; Boston (MA); Remote; USD 200,000 - 221,000; Full time

Job summary

Praxis Precision Medicines, Inc. is seeking an Associate Director of Regulatory Affairs, Advertising & Promotion to lead regulatory review of promotional materials across HCP, DTC, digital channels, and congress materials.

You will ensure accuracy, integrity, and regulatory compliance while guiding campaigns with cross-functional teams in a fast-paced setting. The role requires strong regulatory judgment, ownership, and the ability to navigate PAIE, labeling, and promotional submissions for

Qualifications

• 8+ years in pharma with at least 5 years in regulatory advertising and promotion.
• Deep knowledge of FDA requirements and guidance for prescription drug advertising.
• Experience supporting product launches and PAIE activities preferred.
• Familiarity with Veeva PromoMats, RIM or similar systems.

Responsibilities

• Own regulatory review and approval of advertising and promotional materials across channels.
• Partner with Commercial, Medical Affairs, Legal, Regulatory Strategy, and Regulatory Operations.
• Lead FDA promotional submissions including Form FDA 2253 filings and OPDP interactions.
• Monitor FDA guidance, enforcement trends, and regulatory developments.
• Build scalable advertising review processes and compliant recordkeeping.
• Collaborate with cross-functional teams on labeling, medical education, and market access.

Skills

Regulatory judgment

FDA regulations knowledge

Cross-functional collaboration

Fast-moving decision making

Education

Bachelor's degree in science/health

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

Tools

Veeva PromoMats

RIM

Job description

Praxis Precision Medicines, Inc. is seeking an Associate Director of Regulatory Affairs, Advertising & Promotion to lead regulatory review of promotional materials across HCP, DTC, digital channels, and congress materials.

You will ensure accuracy, integrity, and regulatory compliance while guiding campaigns with cross-functional teams in a fast-paced setting. The role requires strong regulatory judgment, ownership, and the ability to navigate PAIE, labeling, and promotional submissions for