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.
Key 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 RequirementsThe following are
required qualifications to be considered for this role:
- Bachelor's degree in Science.
- 3+ years of experience in promotional regulatory affairs
- FDA advertising/promotion review.
- 5+ years of experience in the pharmaceutical/biotech industry,.
- High ethical standards and commitment to regulatory compliance.
Essential CompetenciesWe 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.
- 5+ years of specific experience in promotional regulatory affairs.
- Proven experience influencing strategic decisions and mentoring teams.
- Direct interaction with OPDP or an FDA review division.
- Experience with products in the therapeutic areas of Oncology, Respiratory/Immunology, or Cardiovascular/Renal/Metabolic.
- Familiarity with electronic review and approval platforms, such as VEEVA PromoMats.
Date Posted15-sept-2026
Closing Date05-oct-2026
