Promotional Regulatory Strategy Director

AstraZeneca GmbH; Wilmington (DE); Hybrid; USD 180,000 - 240,000; Full time

Job summary

AstraZeneca GmbH in the United States seeks a Director of Promotional Regulatory Affairs to steer regulatory promotion strategy across HCP, consumer, and payer audiences, translating science into compliant communications.

Lead risk management, engage with FDA OPDP/APLB, collaborate with Medical, Legal, Commercial, and Corporate Affairs, and build training programs, while guiding brand strategy and lifecycle.

Qualifications

• Bachelor’s degree in science is required.
• 3+ years’ experience in promotional regulatory affairs, FDA (OPDP/APLB), or equivalent.
• 5+ years total experience in pharmaceutical/biotech industry, FDA, or equivalent.

Responsibilities

• Drive regulatory promotion review across HCP, Consumer, and Managed Markets and all media.
• Lead risk and strategy development with contingency planning.
• Collaborate with MLR planners, reviewers, and asset owners on brand strategy alignment.
• Provide global input to US impact on labeling, studies, and corporate initiatives.
• Engage with FDA advisory review and manage enforcement-related matters.
• Develop and deliver regulatory training with internal/external teams.
• Enhance processes to increase speed and quality of reviews.

Skills

FDA regulations

Promotional review

Regulatory strategy

Cross-functional leadership

Drug labeling

Education

Bachelor’s degree in science

Job description

AstraZeneca GmbH in the United States seeks a Director of Promotional Regulatory Affairs to steer regulatory promotion strategy across HCP, consumer, and payer audiences, translating science into compliant communications.

Lead risk management, engage with FDA OPDP/APLB, collaborate with Medical, Legal, Commercial, and Corporate Affairs, and build training programs, while guiding brand strategy and lifecycle.