Senior Manager, FDA-Regulated Advertising Compliance

Alexion Pharma Spain S.L.; Boston (MA); Híbrido; USD 117.000 - 175.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Bonus opportunities

Retirement plan

Health/dental/vision benefits

Descripción de la vacante

AstraZeneca in Boston is seeking a Senior Manager, Advertising and Promotional Compliance to lead US promotional material reviews, ensure FDA-compliant communications, and collaborate with medical, legal, regulatory, and commercial teams to drive safe, effective launches.

You will serve as primary liaison with OPDP/APLB for assigned products, guide labeling changes, and help design and implement compliant submission processes.

Formación

• Bachelor's degree required with 3+ years in US advertising/promotional compliance.
• Experience communicating with OPDP/APLB and advising on labeling changes.
• Demonstrated risk assessment and decision-making in promotional review processes.
• Ability to influence cross-functional teams and manage timelines.
• Knowledge of FDA advertising regulations and industry standards.
• Experience launching products or indications is a plus.

Responsabilidades

• Review US promotional materials and provide regulatory guidance to cross-functional teams.
• Act as primary contact with OPDP/APLB for assigned products and manage FDA form submissions.
• Provide training on promotion compliance and support sales/commercial teams as needed.
• Advise product teams on labeling changes and implementation across materials.
• Develop and improve processes for creating, reviewing, and approving advertising materials.
• Stay current with FDA enforcement actions and industry standards.

Conocimientos

Regulatory knowledge

OPDP liaison

Risk assessment

Team collaboration

Leadership

Prioritization

Product launches

Educación

Bachelor's degree

Advanced degree

Descripción del empleo

AstraZeneca in Boston is seeking a Senior Manager, Advertising and Promotional Compliance to lead US promotional material reviews, ensure FDA-compliant communications, and collaborate with medical, legal, regulatory, and commercial teams to drive safe, effective launches.

You will serve as primary liaison with OPDP/APLB for assigned products, guide labeling changes, and help design and implement compliant submission processes.