Senior Manager Advertising And Promotion Commercial Regulatory Affairs

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Senior Manager, Advertising and Promotion, Commercial Regulatory Affairs
The candidate will provide expert and strategic regulatory advice and risk assessment on promotional issues with guidance from management to ensure that BMS implements product promotion consistent with BMS policies, PhRMA guidelines, FTC guidelines, and applicable FDA regulations and guidance documents. Provide regulatory advice and risk assessment on concepts and final advertising/promotional materials, sales training materials, and external communications for marketed products, as assigned. Assure full regulatory compliance of all promotions with approved labeling, FDA guidance documents, and OPDP advisory comments. Maintain up-to-date knowledge of laws, regulations and policies enforced by the Federal and State governments as they relate to advertising and promotion of pharmaceuticals. Build a strong relationship with internal customers; including Commercial, Legal and Medical. Begin to develop relationships with OPDP. Prepare communications with guidance for OPDP concerning sub part e and advisory submissions. Ensure timely and accurate submission of promotional materials to OPDP on Form 2253. Participate in review of product labeling submissions. Work with management to ensure that changes in US PI are reflected in current promotions and advertising. Handle other duties and/or special projects as assigned. Bachelor’s Life Science degree is required; advanced degree (MS, PhD, PharmD, or J.D.) is preferred. Should have 1-2 years Regulatory promotional review experience. Should have experience providing strategic direction to interdisciplinary teams on promotional materials activities for marketed products and strong interest in FDA advertising and promotional practice regulations including guidance(s).

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