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

Closing Date

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.