AtAstraZeneca Wilmington, we are seeking aPRA 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 inFDA promotional regulations, capable of delivering expert regulatory guidance across assigned brands and key business areas.
AsPRA Director, you will work independently with cross-functional teams, providing risk assessments, strategic advice, and leadership in the review of promotional materials through theMLR (Medical, Legal, Regulatory) Approval Process.
Key Responsibilities
- Efficient review and risk assessmentof all promotional materials across various segments and media, prioritizing deliverables to meet deadlines, including urgent requests.
- Prioritizereviews to meet deadlines, including urgent requests.
- Development and implementation of regulatory strategies, identifying risks and planning contingencies for assigned brands.
- Collaboration with stakeholderson asset prioritization and active participation in consult meetings.
- Advising business leaderson brand strategy and providing input to global teams regarding the impact of U.S. promotional activities.
- Developing departmental guidance documentsand 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 relationshipsacross the business to improve outcomes and enable informed decision-making.
- Mentoring and supportingless experienced staff, serving as asubject matter expertin the field.
Mandatory Minimum Requirements
The following arerequiredqualifications to be considered for this role:
- Bachelor's degree in Science.
- 3+ years of experiencein promotional regulatory affairs
- FDA advertising/promotion review.
- 5+ years of experiencein the pharmaceutical/biotech industry,.
- High ethical standardsand 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 thinkingand sound decision-making under pressure.
- Prioritization and project management skillsin dynamic environments with tight deadlines.
- Attention to detailcombined 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 experiencein promotional regulatory affairs.
- Proven experienceinfluencing strategic decisionsand mentoring teams.
- Direct interaction with OPDPor an FDA review division.
- Experience with products in the therapeutic areas ofOncology, Respiratory/Immunology, or Cardiovascular/Renal/Metabolic.
- Familiarity withelectronic review and approval platforms, such asVEEVA PromoMats.
Why AstraZeneca?
At AstraZeneca, we turn bold ideas into life-changing medicines. Here, your work has a clear purpose:driving access to innovative therapieswhile 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
15-sept-2026
Closing Date
05-oct-2026
Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.