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Job Details
Novartis
AD, Regulatory Advertising & Promotion (Biosimilars) - Remote
Job Description
2015 was the year that Sandoz got approval for the first biosimilar in the United States! Over 20 years of experience in biosimilar development and 8 biosimilars licensed globally have equipped us with extensive knowledge and capabilities in the development, manufacturing and commercialization of biosimilars to increase access to life-saving medicines to patients worldwide. This opportunity is waiting for you to contribute to Sandoz’ success story in the future and at the same time it becomes also the right step up in your career.
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.
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.