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Director, Promotional Regulatory AffairsAstraZeneca · US - Wilmington - DE
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AstraZeneca

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Director, Promotional Regulatory Affairs

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🗓️ Posted 2026-09-16 US - Wilmington - DE Full-time Hybrid Healthcare Medical
💰 Salary Not shared 📊 Market 10,000 EUR–15,000 EUR/mo

About the Company

At AstraZeneca Wilmington , we are seeking a PRA Director (Promotional Regulatory Affairs Director) to join our Promotional Regulatory Affairs team. This is a strategic, high-impact role designed for a professional with deep expertise in FDA promotional regulations , capable of delivering expert regulatory guidance across assigned brands and key business areas. As PRA Director , you will work independently with cross-functional teams, providing risk assessments, strategic advice, and leadership in the review of promotional materials through the MLR (Medical, Legal, Regulatory) Approval Process .

Responsibilities

  • ● Efficient review and risk assessment of all promotional materials across various segments and media, prioritizing deliverables to meet deadlines, including urgent requests.
  • ● Prioritize reviews to meet deadlines, including urgent requests.
  • ● Development and implementation of regulatory strategies , identifying risks and planning contingencies for assigned brands.
  • ● Collaboration with stakeholders on asset prioritization and active participation in consult meetings.
  • ● Advising business leaders on brand strategy and providing input to global teams regarding the impact of U.S. promotional activities.
  • ● Developing departmental guidance documents and supporting materials ( job aids ).
  • ● Serving as liaison with OPDP/APLB , managing FDA advisory reviews, enforcement actions, and competitor complaints.
  • ● Assessing and delivering regulatory training , as well as monitoring emerging regulatory trends and sharing key insights.
  • ● Building strong relationships across the business to improve outcomes and enable informed decision-making.
  • ● Mentoring and supporting less experienced staff, serving as a subject matter expert in the field. Mandatory Minimum Requirements The following are required qualifications to be considered for this role:
  • ● Bachelor's degree in Science .
  • ● + years of experience in promotional regulatory affairs
  • ● FDA advertising/promotion review.
  • ● + years of experience in the pharmaceutical/biotech industry,.
  • ● High ethical standards and commitment to regulatory compliance. Essential Competencies We are looking for candidates who demonstrate:
  • ● Teamwork and effective communication , with strong influencing skills across diverse stakeholders.
  • ● Strategic thinking and sound decision-making under pressure.
  • ● Prioritization and project management skills in dynamic environments with tight deadlines.
  • ● Attention to detail combined with a holistic business perspective. Preferred Experience (Nice to Have) The following attributes will be considered a plus:
  • ● Advanced degree : PharmD, MS, PhD, or JD.