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Associate Director, Promotional Regulatory Affairs
AstraZenecaAssociate 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 fitCore Competencies
Use this summary to align your resume positioning with the role.
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
Tailor your resumeApplicant 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)