Job 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 withmanagement
• 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

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