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Trenton

    Associate Director, Regulatory Affairs, Advertising - Trenton, United States - TANNER & ASSOC INC

    TANNER & ASSOC INC
    TANNER & ASSOC INC Trenton, United States

    Found in: Lensa US 4 C2 - 3 days ago

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    Description
    Associate Director, Regulatory Affairs, Advertising & Promotion—New Jersey

    Tanner and Associates is recruiting an Associate Director, Regulatory Affairs, Advertising & Promotion for a Pharmaceutical Company. This Job is located in New Jersey.

    Responsibilities:
    Provides strategic and operational leadership in advertising and promotion for the US market in accordance with business goals and objectives, FDA regulation, ICH guidelines, PhRMA guidelines and company policy
    Serves as the company's regulatory reviewer for assigned products and the liaison to FDA Division of Drug Marketing, Advertising and Communications (DDMAC)
    Works closely with Marketing Brand Teams, Legal, Medical Affairs and Clinical Research in the development of advertising and promotional materials to support the commercial interests of the business and comply with applicable FDA regulations
    Represents Regulatory Affairs on the company's Promotional Review Committee and provides guidance on current regulatory environment and regulatory considerations that may impact business activities
    Trains company personnel as it pertains to regulatory aspects of advertising and promotion, especially in the area of exhibit booth activities
    Provides recommendations to Medical Affairs Teams on Phase IV clinical trial design regarding promotability of potential data/claims
    Works with US Regulatory Manager on International Product Teams to insure that regulatory strategy will result in commercially viable US labeling in which future promotion and advertising will be affected
    Participates in US labeling negotiations and FDA meetings as necessary
    Ensures that changes in US prescribing information are reflected in current promotion and advertising

    Requirements :
    PhD or PharmD with 4-6 years of related industry experience; or, FDA or MS degree with 7-10 years industry experience; or, BS degree with 12 years industry experience, including 2 + years of local regulatory experience
    Experience in regulatory review of professional and consumer Rx drug advertising and promotion
    Experience in leading activities necessary for promotional DDMAC submissions (including pre-clearance "time of first use" submissions)
    Experience with regulatory activities involved with a product launch; and an understanding of business goals of the involved business franchise, marketing concepts and tools
    Track record of demonstrated leadership skills and ability to interact with management
    Excellent written and verbal communication abilities are essential
    Expert knowledge of the pharmaceutical business and proficiency at representing/interpreting the strategic business objectives of the company

    #J-18808-Ljbffr
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