AstraZeneca
Director Promotional Regulatory Affairs
Wilmington, Delaware, United States of America · Director
Sponsorship not specifiedDetected 1 day ago
SparkBrand StrategyFDA RegulatoryLeadershipCommunicationMentoringRegulatory Affairs
About the role
- Are you ready to steer US promotional regulatory strategy in a way that accelerates responsible growth and earns patient and prescriber trust?
- As Director of Promotional Regulatory Affairs, you will set the regulatory guardrails that enable confident brand execution and speed.
- Your expertise with FDA engagement will help anticipate risk and convert it into sound strategy.
Responsibilities
- Join a high-energy, commercially savvy environment that develops leaders who know how the enterprise runs and what excellence looks like in bringing innovation to patients.
- Drive efficient and effective regulatory review and risk assessment for promotional materials across HCP, Consumer, and Managed Markets segments and all media types, including sales and faculty training, scientific exchange, and Corporate Affairs communications, through established systems. -
- Collaborate with MLR planners, reviewers, and asset owners on asset prioritization and consultation; advise business leadership on Brand strategy to ensure claims and evidence align with regulatory expectations. -
- Serve as primary liaison with OPDP/APLB for assigned brands; manage requests for FDA advisory review, address enforcement actions, and adjudicate incoming/outgoing competitor product complaints to protect brand integrity. -
- Follow and enhance established processes and guidelines; develop PRA guidance documents and job aids that increase clarity, speed, and quality in review and approval. -
- Act as a role model for performance and ways of working; manage, develop, and mentor less experienced staff to elevate team capability. -
Skills
- Bachelor's degree in science
- 3+ years' experience in promotional regulatory affairs, FDA (OPDP/APLB), or other equivalent experience in advertising and promotion review
- 5+ years total experience in pharmaceutical/biotech industry, FDA, or equivalent experience
- Strong knowledge of FDA promotional regulations and ability to apply such knowledge in review of diverse promotional materials and audiences
- Knowledge of the drug development and labeling processes
- Advanced degree in life sciences, pharmacy, law, or a related discipline
- Experience leading or co-chairing MLR processes and operating within digital review systems such as AZAP or comparable platforms
- Launch-to-lifecycle leadership across HCP and consumer promotions, managed markets materials, and omnichannel/digital campaigns
- Demonstrated influence at senior levels to shape departmental practices and operational plans
Benefits
- Shape PRA vision, practices, and operational plans; contribute to team objectives and priorities with a focus on measurable outcomes and continuous improvement. -
- This role translates science into clear, compliant communication across healthcare professionals, consumers, and payers-so that what we say is as strong as the medicines we deliver.
Company info
- Represent the company as a subject matter expert internally and externally, reinforcing credibility and thought leadership in promotional regulatory affairs.
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This listing is sourced directly from AstraZeneca's careers page and normalized into a canonical job model.