Director, Promotional Regulatory Affairs

AstraZeneca

Director of Promotional Regulatory Affairs at AstraZeneca steering US regulatory strategies for promotional materials. Collaborating with cross-functional teams to ensure compliance and drive brand success.

Posted 6/4/2026full-timeMaryland • 🇺🇸 United StatesLeadWebsite

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

regulatory reviewrisk assessmentregulatory strategy developmentbrand regulatory trainingPRA guidance developmentpromotional material reviewFDA advisory reviewdrug development processeslabeling processescontingency planning

Soft Skills

collaborationleadershipmentoringcommunicationstrategic thinkingproblem-solvingperformance managementcontinuous improvementconsultationinfluencing

Certifications & Qualifications

Bachelor’s degree in science

Industry Keywords

promotional regulatory affairsFDAOPDPAPLBpharmaceutical industrybiotech industryadvertising reviewpromotion reviewcompliancebrand integrity

About the role

Key responsibilities & impact

Drive efficient and effective regulatory review and risk assessment for promotional materials across HCP, Consumer, and Managed Markets segments and all media types
Lead innovative regulatory strategy development and implementation, including risk identification and contingency planning that safeguard brands while enabling bold, compliant storytelling
Collaborate with MLR planners, reviewers, and asset owners on asset prioritization and consultation; advise business leadership on Brand strategy to ensure claims and evidence align with regulatory expectations
Provide input to global teams on how proposed TPP/TPC/TPL documents, labeling, studies, and corporate initiatives may affect US promotion; translate insights into clear guidance for US stakeholders
Serve as primary liaison with OPDP/APLB for assigned brands; manage requests for FDA advisory review, address enforcement actions, and adjudicate incoming/outgoing competitor product complaints to protect brand integrity
Evaluate brand regulatory training needs and develop and deliver training in partnership with internal/external Learning teams or the PRA Skill Center, building regulatory acumen across the business
Follow and enhance established processes and guidelines; develop PRA guidance documents and job aids that increase clarity, speed, and quality in review and approval
Monitor regulatory agency activities, guidance documents, and emerging trends; distill and share implications with PRA and cross-functional partners to inform proactive planning
Shape PRA vision, practices, and operational plans; contribute to team objectives and priorities with a focus on measurable outcomes and continuous improvement
Act as a role model for performance and ways of working; manage, develop, and mentor less experienced staff to elevate team capability
Represent the company as a subject matter expert internally and externally, reinforcing credibility and thought leadership in promotional regulatory affairs

Requirements

What you’ll need

Bachelor’s degree in science
3+ years’ experience in promotional regulatory affairs, FDA (OPDP/APLB), or other equivalent experience in advertising and promotion review
5+ years total experience in pharmaceutical/biotech industry, FDA, or equivalent experience
Strong knowledge of FDA promotional regulations and ability to apply such knowledge in review of diverse promotional materials and audiences
Knowledge of the drug development and labeling processes

Benefits

Comp & perks

In-person working with minimum of three days per week from the office
Flexible working arrangements
Professional development opportunities