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Associate Director, Regulatory Affairs (Advertising and Promotion)

BioNTech
onsite
Cambridge, US; New Jersey, US

About this role

Position Summary

The Associate Director, Regulatory Affairs (Advertising and Promotion) will have accountability for review and approval of US promotional materials and medical communications of assigned brand(s). This colleague will provide input and execute regulatory compliance/strategy related to promotional and advertising campaigns for marketed products and development projects. Provides input into labeling strategies for investigational and marketed products impacting potential US product promotion and is responsible for leading interactions with the FDA Office of Prescription Drug Promotion (OPDP) and Advertising and Promotion Labeling Branch (APLB) pertinent to assigned brand(s). The individual will be responsible for all submission types made to OPDP/APLB (FDA).

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