Associate Director, Promotional Regulatory Affairs (BBU)
AstraZeneca · Gaithersburg, MD
RegulatoryFull-time$150k–$225kCompany career page
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Role summary
Associate Director position in promotional regulatory affairs at AstraZeneca's Gaithersburg location. The role involves reviewing promotional materials across multiple formats and audiences, providing FDA regulatory guidance to cross-functional teams, and ensuring compliance with pharmaceutical advertising regulations.
What they're looking for
- Bachelor's degree in pharmacy, pharmacology, life science, or related field
- 5+ years regulatory affairs experience in pharmaceutical or biotech industry
- Working knowledge of FDA promotional regulations and application to diverse materials
- Understanding of drug development processes
- Electronic review system experience (VEEVA PromoMats or similar) preferred
What you'll be doing
- Review promotional materials across segments and media through AstraZeneca approval process
- Provide regulatory guidance and risk assessment to cross-functional business partners
- Manage FDA advisory reviews and competitor complaint adjudication
- Develop regulatory training and guidance documents for internal and cross-functional use
- Monitor regulatory trends and emerging guidance to inform strategy
Privacy & handoff
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