Director, Promotional Regulatory Affairs

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 Requirements The 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 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. • 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 . Why AstraZeneca? At AstraZeneca, we turn bold ideas into life-changing medicines. Here, your work has a clear purpose:   driving access to innovative therapies   while upholding the highest standards of regulatory compliance. We offer a collaborative environment, continuous professional development opportunities, and the chance to work alongside some of the brightest minds in the industry. Ready to take the next step in your career?   Apply today and become part of a team redefining the future of healthcare. Date Posted 04-Nov-2026 Closing Date 03-Dec-2026 Our mission is to build an inclusive environment where equal employment o