Director, Promotional Regulatory Affairs: US Strategy & Compliance

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

Job summary

AstraZeneca GmbH is seeking a Director of Promotional Regulatory Affairs to steer US promotional regulatory strategy. You will translate science into clear, compliant communications across healthcare professionals, consumers, and payers, shaping claims early and ensuring high standards across all media.

Lead risk-aware regulatory strategy, partner with Medical, Legal, Commercial and Corporate Affairs, and engage with OPDP/APLB.

Qualifications

• Bachelor’s degree in science; 3+ years’ experience in promotional regulatory affairs or related advertising review; 5+ years total in pharma/biotech.
• Strong knowledge of FDA promotional regulations and ability to apply them across materials and audiences
• Experience collaborating with Medical, Legal, Commercial and Corporate Affairs to align promotion.

Responsibilities

• Regulatory Promotion Review: drive efficient review and risk assessment for promotional materials across all channels.
• Risk and Strategy Leadership: develop and implement regulatory strategy with contingency planning.
• Cross-Functional Partnership: advise asset owners and leadership on Brand strategy and regulatory expectations.
• Global Input for US Impact: provide input to global teams on documents, labeling, and studies affecting US promotion.
• External Agency Engagement: liaise with FDA agencies; manage advisory reviews and enforcement matters.
• Training and Capability Building: identify training needs and deliver programs.
• Process Excellence: improve PRA processes and guidance documents.
• Intelligence and Foresight: monitor agency actions and trends; inform planning.
• Departmental Contribution: shape PRA vision and operational plans.
• People Leadership and Mentorship: mentor staff to elevate team capability.
• Subject Matter Representation: represent company as regulatory affairs SME.

Skills

Regulatory affairs

FDA regulations

Cross-functional collaboration

Strategic thinking

Training & capability building

Education

Bachelor’s degree in science

Advanced degree in life sciences or law

Tools

AZAP

Job description

AstraZeneca GmbH is seeking a Director of Promotional Regulatory Affairs to steer US promotional regulatory strategy. You will translate science into clear, compliant communications across healthcare professionals, consumers, and payers, shaping claims early and ensuring high standards across all media.

Lead risk-aware regulatory strategy, partner with Medical, Legal, Commercial and Corporate Affairs, and engage with OPDP/APLB.