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Director, Promotional Regulatory Affairs
AstraZenecaDirector of Promotional Regulatory Affairs at AstraZeneca responsible for US promotional regulatory strategy and regulatory review of promotional materials across all channels.
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
- Collaborate with MLR planners, reviewers, and asset owners on asset prioritization and consultation
- Provide input to global teams on how proposed documents, labeling, studies, and corporate initiatives may affect US promotion
- Serve as primary liaison with OPDP/APLB for assigned brands
- Evaluate brand regulatory training needs and develop and deliver training
- Follow and enhance established processes and guidelines
- Monitor regulatory agency activities, guidance documents, and emerging trends
- Shape PRA vision, practices, and operational plans
- Act as a role model for performance and ways of working
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- Health insurance
- 401(k) matching
- Flexible work arrangements
- Professional development
ATS Keywords
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Hard Skills & Tools
regulatory reviewrisk assessmentregulatory strategy developmentpromotional regulatory affairsFDA regulationsdrug development processeslabeling processestraining developmentconsultationasset prioritization
Soft Skills
collaborationleadershipcommunicationperformance modelingorganizational skills
Certifications
Bachelor’s degree in science