AD, Regulatory Advertising & Promotion (Biosimilars) - Remote
The Associate Director of Regulatory Advertising and Promotion is responsible for strategic leadership of regulatory reviews and guidance relating to promotional activities for assigned products.
Your responsibilities will include, but are not limited to:
• Serving as a regulatory reviewer for assigned products. Ensures regulatory compliance while effectively managing business risks.
• Ensures that strategic regulatory subject matter expertise is provided on advertising and promotional materials/activities for assigned products in accordance with business goals and objectives, FDA regulations/guidances, PhRMA guidelines and company policy
• Reviews relevant medical and clinical development non-promotional materials in accordance with company policies.
• Primary liaison with Office of Prescription Drug Promotion (OPDP) regarding advertising and promotion for assigned products, including authoring responses to OPDP letters
• Monitors US regulatory promotional environment by staying up-to-date on FDA regulations and guidances, reviewing untitled and warning letters to pharmaceutical companies published by OPDP, and by attendance at major FDLI, DIA, and other industry/FDA meetings (when appropriate)
• Participates in due diligence activities for potential licensing and acquisition opportunities that are being evaluated by the company.
• Responsible for researching, review and interpretation of related product approvals, current regulatory guidance documents and recent public Advisory Committee proceedings, to support the development of optimal regulatory strategies to ensure complete submissions and achievement of target product labeling
Please note that this role would not provide relocation as a result. If associate is remote, all home office expenses and any travel/lodging to Princeton, NJ for periodic live meetings will be at the employee’s expense. The expectation of working hours and travel (domestic and/or international) will be defined by the hiring manager.