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AstraZeneca

Associate Director, Promotional Regulatory Affairs

AstraZeneca

Associate Director overseeing promotional regulatory affairs compliance for AstraZeneca. Engaging with cross-functional teams to ensure promotional materials meet federal regulations while managing a diverse workload in a complex environment.

Posted 7/23/2026full-timeGaithersburg • Maryland • 🇺🇸 United StatesSenior💰 $150,098 - $225,147 per yearWebsite

Core Competencies

Role fit
Core Competencies

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Demonstrates expertise in regulatory review and risk assessment of promotional materials across various segments and media, with a strong understanding of FDA regulations and the drug development process. Capable of developing guidance and job aids for cross-functional collaboration while monitoring regulatory trends.

Highest-signal resume keywords
Regulatory Affairs ExperienceFDA Promotional RegulationsDrug Development ProcessElectronic Review ProgramsCross-Functional Collaboration

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills
Regulatory ReviewRisk AssessmentPromotional Material ReviewGuidance DevelopmentRegulatory Monitoring
Tools & Technologies
VEEVA PromoMats
Certifications & Qualifications
Bachelor's Degree in PharmacyBachelor's Degree in PharmacologyBachelor's Degree in Life Science
Industry Keywords
PharmaceuticalBiotechHCPConsumerManaged Markets

About the role

Key responsibilities & impact
  • Ensure efficient and effective regulatory review and risk assessment of promotional material for all segments (HCP, Consumer, Managed Markets) and media (Print, broadcast and electronic)
  • Conduct reviews within established timelines and meets expedited requests as priorities and workload allow
  • Develop PRA guidance and job aids on relevant topics for use within the department and for use by cross-functional partners as appropriate
  • Monitor regulatory agency activities, new guidance, and emerging trends in the regulatory environment

Requirements

What you’ll need
  • Bachelors Degree in pharmacy, pharmacology, life science, or related field or equivalent experience a plus
  • 5 years’ experience in drug/biologic regulatory affairs or related pharmaceutical/biotech field
  • Working knowledge of FDA promotional regulations and ability to apply such knowledge in review of diverse promotional materials and audiences
  • Working knowledge of the drug development process
  • Experience with electronic review and approval programs (VEEVA PromoMats or other) a plus

Benefits

Comp & perks
  • Health insurance
  • Retirement programs
  • Paid time off (i.e., vacation, holiday, and leaves)