Remote Regulatory Affairs Lead — Advertising & Promotion

Praxis Precision Medicines, Inc.; EE. UU.; A distancia; USD 200.000 - 221.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health coverage

Life insurance

AD&D

Disability benefits

401(k) match

Stock incentives

ESPP

Quarterly bonus

Wellness benefit

Generous PTO

Paid holidays

Company shutdowns

Descripción de la vacante

Praxis Precision Medicines is seeking an Assistant Director, Regulatory Affairs, Advertising & Promotion to lead the regulatory review and approval of promotional materials. You will work with Commercial, Medical Affairs, Legal, and Regulatory Operations to build a scalable review capability with strong regulatory judgment.

The role demands ownership, urgency, and collaboration across Praxis teams, including ongoing oversight of Form FDA 2253 submissions and OPDP interactions.

Formación

• Deep knowledge of FDA requirements and guidance for prescription drug advertising.
• Experience supporting product launches and PAIE activities.
• Ability to apply regulatory judgment in fast-moving environments.

Responsabilidades

• Own regulatory review and approval of advertising and promotional materials across channels.
• Apply regulatory judgment to ensure accuracy and compliance with FDA rules.
• Partner with Commercial, Medical Affairs, and Legal to shape campaigns and minimize delays.
• Own FDA promotional submissions including Form FDA 2253 and OPDP interactions.
• Monitor FDA guidance and translate trends into actionable recommendations.
• Build scalable advertising processes with records, archiving, and systems like Veeva PromoMats and RIM.
• Serve as regulatory partner across Praxis and cross-functional teams on launches and education.

Conocimientos

Regulatory affairs

FDA regulations

Promotional review

Leadership

Cross-functional collaboration

Veeva PromoMats

RIM

PAIE knowledge

Educación

Bachelor’s degree in science/health

PharmD or MD or PhD or JD

Herramientas

Veeva PromoMats

RIM

Descripción del empleo

Praxis Precision Medicines is seeking an Assistant Director, Regulatory Affairs, Advertising & Promotion to lead the regulatory review and approval of promotional materials. You will work with Commercial, Medical Affairs, Legal, and Regulatory Operations to build a scalable review capability with strong regulatory judgment.

The role demands ownership, urgency, and collaboration across Praxis teams, including ongoing oversight of Form FDA 2253 submissions and OPDP interactions.