Associate Director, Regulatory Affairs Advertising & Promotion

Bringing life-changing medicines to millions of people, Novartis sits at the intersection of cutting-edge medical science and innovative digital technology. As a global company, the resources and opportunities for growth and development are plentiful including global and local cross functional careers, a diverse learning suite of thousands of programs & an in-house marketplace for rotations & project work. With a strong medicines pipeline our current transformation will not just deliver growth for our business but continue to allow us to bring innovative medicines to patients quickly.<br><br>The <b>Associate Director, Regulatory Affairs Advertising & Promotion</b> will provide strategic regulatory advice on advertising/promotion and medical materials to the US organization for assigned products in accordance with business goals and objectives, FDA regulations/guidances, PhRMA guidelines, and company policy.<br><br><b>Your responsibilities will include but are not limited to:</b> <br>• Serves as a primary regulatory advertising and promotion reviewer for assigned products on Materials Approval Process (“MAP”) teams. May include a launch product or indication with manager oversight.<br>• Liaison with OPDP regarding advertising and promotion for assigned products, including products approved under Subpart H with manager oversight. Establishes strong and positive working relationship with OPDP reviewers. Manages OPDP queries on assigned products.<br>• Applies regulatory and therapeutic area knowledge to Brand Team’s objectives and initiatives to develop solutions to US promotional issues.<br>• Ensures regulatory compliance while effectively managing business risks.<br>• Maintains awareness of competitive activities by monitoring major US Medical meetings where assigned therapeutic area products are promoted.<br>• Prepares complaint letters to OPDP with manager oversight.<br>• Conduct reviews of materials to be used by medical personnel in discussions with customers.<br>• Monitors US regulatory promotional environment by reviewing regulatory promotional guidelines, untitled and warning letters to pharmaceutical companies published by OPDP, and by attendance of major FDLI, DIA and other industry/FDA meetings.<br>• Collaborates with Regulatory Affairs colleagues to provide input to study designs or US label regarding feasibility of promoting potential data/claims with manager oversight.<br>• Participates/assists in US labeling negotiations and FDA meetings as necessary.<br>• Ensures that changes in US Prescribing Information are reflected in current promotion and advertising.<br><br>[#video#https://www.youtube.com/watch?v=ggbnzRY9z8w{#400,300#}#/video#]